# Gastroenterology, Urology device clearances: 813

Updated October 30, 2026.

FDA made 813 device decisions in gastroenterology, urology (FDA review panel) from November 12, 2024 to October 30, 2026: 502 510(k) clearances and De Novo grants and 311 PMA approvals and supplements, for 301 applicants. The newest, P250025/S002 on October 30, 2026, is TorEx Lung Perfusion System; TorEx Lung Perfusate from Traferox Technologies, Inc..

## The full list

FDA gastroenterology, urology device clearances and approvals: 813 rows for $40.65, FDA 510(k) and PMA decisions dated November 11, 2024 to October 30, 2026. Columns: Number, Pathway, Device name, Applicant, Applicant address, Contact, Decision, Decision date, Decision type, Date received, Product code, Device type, Device class, Panel, Applicant state, Applicant country, Supplement reason, Read on, Source. The new rows each week by email, about 37 rows a month: $19 a month. Pay by card with no account. Prices exclude VAT. CSV and Excel files with the columns this page does not show (contact, pathway, device name, applicant address, date received, device type and 6 more), which open on your screen as soon as the payment clears and come by email. The rows on this page are a sample.

Buy: https://specstream.ai/data/fda-clearances/panel/gastroenterology-urology

SpecStream is the live web data engine for teams and agents. It reads every new FDA device clearance and approval as openFDA publishes it, and this page is that reading. Ask for the specialties, product codes or states you follow and each new decision arrives in your sheet, CRM, Slack or agent with the applicant and its address.

- Decisions: 813
- 510(k) and De Novo: 502
- PMA: 311
- Latest decision: October 30, 2026

## Newest decisions

The newest 100 of 813, each linked to its FDA record. The full list adds the applicant's address, the 510(k) contact as FDA prints it, the device class and the date received.

| Decision date | Number | Device | Applicant | Location | Decision | Type | Product code | Source |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| October 30, 2026 | P250025/S002 | TorEx Lung Perfusion System; TorEx Lung Perfusate | Traferox Technologies, Inc. |  | Approved | PMA 180-day supplement | PHO | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P250025S002) |
| October 30, 2026 | P250025/S001 | TorEx Lung Perfusion System; TorEx Lung Perfusate | Traferox Technologies, Inc. |  | Approved | PMA 180-day supplement | PHO | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P250025S001) |
| October 30, 2026 | K263592 | da Vinci Xi Surgical System (IS4000);da Vinci X Surgical System (IS4200) | Intuitive Surgical, Inc. | California | Substantially Equivalent | 510(k) special | NAY | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K263592) |
| October 30, 2026 | K263075 | Strauss Surgical Cystoscope/Hysteroscope and Accessories Instruments | Strauss Surgical USA | Florida | Substantially Equivalent | 510(k) traditional | FAJ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K263075) |
| October 29, 2026 | P970004/S460 | InterStim™ Therapy System, Verify™ Evaluation System (SNS Urinary Neurostimulator 97800), (SNS Urinary... | Medtronic Neuromodulation | Minnesota | 30-day notice accepted | PMA 30-day notice | EZW | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P970004S460) |
| October 29, 2026 | P080025/S354 | InterStim™ Therapy System, Verify™ Evaluation System (SNS Bowel Neurostimulator 97800), (SNS Bowel... | Medtronic Neuromodulation | Minnesota | 30-day notice accepted | PMA 30-day notice | QON | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P080025S354) |
| October 29, 2026 | K263459 | SWICS™ | Bloom Surgical, Inc. | Utah | Substantially Equivalent | 510(k) traditional | GCJ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K263459) |
| October 29, 2026 | K262437 | Single-use Digital Flexible Ureteroscope (GY-UR6.3); Single-use Digital Flexible Ureteroscope (GY-UR6.3A) | Zhejiang Geyi Medical Instrument Co., Ltd. | China | Substantially Equivalent | 510(k) traditional | FGB | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262437) |
| October 28, 2026 | P160013/S023 | Organ Care System (OCS™) Lung System | TransMedics, Inc. | Massachusetts | 30-day notice accepted | PMA 30-day notice | QBA | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P160013S023) |
| October 28, 2026 | K263512 | Luja female | Coloplast Corp. | Minnesota | Substantially Equivalent | 510(k) special | EZD | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K263512) |
| October 27, 2026 | K262531 | OnControl Powered Bone Access Systems;OnControl Bone Marrow Aspiration System;OnControl Bone Marrow Biopsy... | Teleflex Medical, LLC | North Carolina | Substantially Equivalent | 510(k) traditional | KNW | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262531) |
| October 26, 2026 | K260350 | Cysto-Urethroscopes and accessories | Hangzhou Hawk Optical Electronic Instruments Co., Ltd. | China | Substantially Equivalent | 510(k) traditional | FJL | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260350) |
| October 23, 2026 | K261670 | Polymed TUR Irrigation Set, Single Spike, Tubing 90 with Luer Lock - Sterile (30031 ); Polymed TUR Irrigation... | Poly Medicure Limited | India | Substantially Equivalent | 510(k) traditional | LJH | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261670) |
| October 20, 2026 | K260708 | Vein360 Reprocessed LithoVue Digital Flexible Ureteroscope (Standard Deflection); Vein360 Reprocessed... | Vein 360 | Ohio | Substantially Equivalent | 510(k) traditional | FGB | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260708) |
| October 19, 2026 | K261203 | multiFiltratePRO System | Fresenius Medical Care Renal Therapies Group, LLC | Massachusetts | Substantially Equivalent | 510(k) traditional | KDI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261203) |
| October 16, 2026 | P240033/S002 | LungFX™ Device | Lung Bioengineering, Inc. | Maryland | Approved | PMA 180-day supplement | PHO | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P240033S002) |
| October 16, 2026 | P240033/S001 | LungFX™ Device | Lung Bioengineering, Inc. | Maryland | Approved | PMA 180-day supplement | PHO | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P240033S001) |
| October 14, 2026 | P050027/S038 | Photodynamic Diagnostic D-Light C System | KARL STORZ Endoscopy-America, Inc. | California | 30-day notice accepted | PMA 30-day notice | OAY | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P050027S038) |
| October 14, 2026 | K262455 | da Vinci 5 Handheld Camera Head (470080);da Vinci 5 Handheld Camera Laparoscope, 0 degree (470081);da Vinci 5... | Intuitive Surgical, Inc. | California | Substantially Equivalent | 510(k) traditional | GCJ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262455) |
| October 14, 2026 | K262044 | Mediclose Cartridge System | Health Value Creation B.V. (trading as Corporis Medical) | Netherlands | Substantially Equivalent | 510(k) traditional | OCW | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262044) |
| October 9, 2026 | P970004/S459 | InterStim™ Therapy System, Verify™ Evaluation System | Medtronic Neuromodulation | Minnesota | 30-day notice accepted | PMA 30-day notice | EZW | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P970004S459) |
| October 9, 2026 | P200035/S038 | OrganOx metra® System | Organox Limited |  | Approved | PMA 180-day supplement | QQK | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P200035S038) |
| October 9, 2026 | P080025/S353 | InterStim™ Therapy System, Verify™ Evaluation System | Medtronic Neuromodulation | Minnesota | 30-day notice accepted | PMA 30-day notice | QON | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P080025S353) |
| October 6, 2026 | P970004/S457 | InterStim™ Therapy System, Verify™ Evaluation System | Medtronic Neuromodulation | Minnesota | Approved | PMA real-time process supplement | EZW | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P970004S457) |
| October 6, 2026 | P080025/S351 | lnterStim™ Therapy System, Verify™ Evaluation System | Medtronic Neuromodulation | Minnesota | Approved | PMA real-time process supplement | QON | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P080025S351) |
| October 6, 2026 | K261141 | OpenFlo Urinary Catheter | Urolution Medical, Inc. | Minnesota | Substantially Equivalent | 510(k) traditional | EZL | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261141) |
| October 2, 2026 | P230019/S005 | MediBeacon Transdermal GFR System | Medibeacon, Inc. | Missouri | Approved | PMA special supplement | SDK | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P230019S005) |
| October 2, 2026 | K261791 | MEDIVATORS™ ADVANTAGE NXT™ Automated Endoscope Reprocessor | Steris | Ohio | Substantially Equivalent | 510(k) traditional | FEB | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261791) |
| October 2, 2026 | K261783 | Plenity-V (MC0979 / GS110) | Gelesis SRL | Italy | Substantially Equivalent | 510(k) traditional | QFQ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261783) |
| October 2, 2026 | K261741 | Hemostatic Clip | Anrei Medical (Hz) Co., Ltd. | China | Substantially Equivalent | 510(k) traditional | PKL | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261741) |
| October 2, 2026 | K260487 | stentFIX System Set (100.50n) | Ovesco Endoscopy AG | Germany | Substantially Equivalent | 510(k) traditional | PKL | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260487) |
| September 30, 2026 | K262621 | Rapid Barostat Bag (RBB) Pump and Catheter System | Mui Scientific, Inc. | Canada | Substantially Equivalent | 510(k) special | FFX | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262621) |
| September 30, 2026 | K262038 | danumed StomaMeter | Danumed Medizintechnik GmbH | Germany | Substantially Equivalent | 510(k) traditional | KNT | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262038) |
| September 25, 2026 | K254230 | CapsoView (CVV); CapsoCloud (CLD) | CapsoVision, Inc. | California | Substantially Equivalent | 510(k) traditional | QZF | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254230) |
| September 24, 2026 | P250011/S006 | ProVee System for BPH | Proverum, Ltd. |  | Approved | PMA special supplement | MER | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P250011S006) |
| September 23, 2026 | P250023/S002 | Allurion™ Gastric Balloon System | Allurion Technologies, Inc. | Massachusetts | Approved | PMA 180-day supplement | LTI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P250023S002) |
| September 23, 2026 | K262353 | BTL-299-F | BTL Industries, Inc. | Massachusetts | Substantially Equivalent | 510(k) traditional | KPI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262353) |
| September 23, 2026 | K261418 | Liquick X-treme, Liquick X-treme Plus | Teleflex Medical | Ireland | Substantially Equivalent | 510(k) traditional | EZD | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261418) |
| September 21, 2026 | K262547 | KARL STORZ TIPCAM1 Rubina | KALR STORZ SE & Co. KG | Germany | Substantially Equivalent | 510(k) traditional | OWN | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262547) |
| September 21, 2026 | K260512 | Disposable Ureteral Access Sheath | Yangzhou Fartley Medical Instrument Technology Co., Ltd. | China | Substantially Equivalent | 510(k) traditional | FED | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260512) |
| September 18, 2026 | K262262 | Pathfinder Endoscope Overtube | Neptune Medical, Inc. | California | Substantially Equivalent | 510(k) traditional | FED | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262262) |
| September 18, 2026 | K254179 | Drainage Catheter | Canyon Medical, Inc. | China | Substantially Equivalent | 510(k) traditional | FGE | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254179) |
| September 17, 2026 | K262913 | Protégé™ EverFlex™ Self-expanding Peripheral Stent System | Medtronic, Inc. | Minnesota | Substantially Equivalent | 510(k) special | FGE | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262913) |
| September 16, 2026 | P180014/S014 | XPS™ with Steen Solution™ Perfusate | Xvivo Perfusion, Inc. | Colorado | Approved | PMA real-time process supplement | PHO | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P180014S014) |
| September 16, 2026 | K261913 | X°Port Heart Preservation System | Traferox Technologies, Inc. | Canada | Substantially Equivalent | 510(k) traditional | MSB | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261913) |
| September 16, 2026 | K261400 | Ambu® aScope™ Gastro; Ambu® aScope™ Gastro Large | Ambu A/S | Denmark | Substantially Equivalent | 510(k) traditional | FDS | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261400) |
| September 15, 2026 | K261447 | CVAC® Aspiration System | Calyxo, Inc. | California | Substantially Equivalent | 510(k) traditional | FGB | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261447) |
| September 14, 2026 | P970004/S458 | InterStim™ Therapy System Verify™ Evaluation System | Medtronic Neuromodulation | Minnesota | 30-day notice accepted | PMA 30-day notice | EZW | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P970004S458) |
| September 14, 2026 | P240011/S016 | Altaviva™ | Medtronic Neuromodulation | Minnesota | 30-day notice accepted | PMA 30-day notice | QPT | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P240011S016) |
| September 14, 2026 | P080025/S352 | InterStim™ Therapy System, Verify™ Evaluation System | Medtronic Neuromodulation | Minnesota | 30-day notice accepted | PMA 30-day notice | QON | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P080025S352) |
| September 14, 2026 | P000053/S142 | AMS 800™ Artificial Urinary Sphincter (AUS) | Boston Scientific Corp | Massachusetts | 30-day notice accepted | PMA 30-day notice | EZY | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P000053S142) |
| September 14, 2026 | N970012/S212 | AMS 700™ Inflatable Penile Prosthesis (IPP) | Boston Scientific Corp | Massachusetts | 30-day notice accepted | PMA 30-day notice | JCW | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=N970012S212) |
| September 14, 2026 | K253481 | colonic FTRD Set (200.70); diagnostic FTRD Set (200.76); gastroduodenal FTRD Set (200.72) | Ovesco Endoscopy AG | Germany | Substantially Equivalent | 510(k) traditional | PKL | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253481) |
| September 12, 2026 | K260133 | CADDIE | Odin Medical Limited | United Kingdom | Substantially Equivalent | 510(k) special | QNP | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260133) |
| September 11, 2026 | K262397 | CuratOR EX2742 | Eizo Corporation | Japan | Substantially Equivalent | 510(k) traditional | GCJ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262397) |
| September 11, 2026 | K260410 | Single Use Ureteral Access Sheath | Zhejiang Chuangxiang Medical Technology Co., Ltd. | China | Substantially Equivalent | 510(k) special | FED | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260410) |
| September 10, 2026 | K262079 | 4K Camera Head OLYMPUS CH-S700-08-LB | Olympus Medical Systems Corp. | Japan | Substantially Equivalent | 510(k) traditional | FET | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262079) |
| September 10, 2026 | K260110 | danumed Extension Set for Gastrostomy Button | Danumed Medizintechnik GmbH | Germany | Substantially Equivalent | 510(k) traditional | PIF | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260110) |
| September 10, 2026 | K254111 | Irrigation/Urology Sets | B.Braun Medical, Inc. | Pennsylvania | Substantially Equivalent | 510(k) traditional | LJH | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254111) |
| September 9, 2026 | P250023/S001 | Allurion™ Gastric Balloon System | Allurion Technologies, Inc. | Massachusetts | Approved | PMA special supplement | LTI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P250023S001) |
| September 9, 2026 | P200036/S012 | eCoin Peripheral Neurostimulator | Boston Scientific Corporation | Massachusetts | 30-day notice accepted | PMA 30-day notice | QPT | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P200036S012) |
| September 9, 2026 | K262488 | Single-Use Video Flexible Ureterorenoscope (RP-U-C06R9, RP-U-C06R3, RP-U-C06S9, RP-U-C06S3) | Guangzhou Red Pine Medical Instrument Co., Ltd. | China | Substantially Equivalent | 510(k) traditional | FGB | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262488) |
| September 9, 2026 | K261470 | QF10 | E.A.M Benelux B.V | Netherlands | Substantially Equivalent | 510(k) traditional | NHV | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261470) |
| September 9, 2026 | K260997 | SIS BLU (SISBLU-30-01);SIS BLU (SISBLU-15-01) | Endoclot Plus Co., Ltd. | China | Substantially Equivalent | 510(k) traditional | PLL | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260997) |
| September 8, 2026 | K261823 | da Vinci Surgical System, Model IS5000 | Intuitive Surgical, Inc. | California | Substantially Equivalent | 510(k) traditional | NAY | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261823) |
| September 4, 2026 | K262292 | Gastric Alimetry | Alimetry , Ltd. | New Zealand | Substantially Equivalent | 510(k) traditional | MYE | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262292) |
| September 4, 2026 | K260756 | TraumaGuard Intra-Abdominal Pressure-Sensing System (000-0221) | Sentinel Medical Technologies, | Florida | Substantially Equivalent | 510(k) traditional | EZL | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260756) |
| September 3, 2026 | K262460 | Rezum System | Boston Scientific | Massachusetts | Substantially Equivalent | 510(k) traditional | KNS | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262460) |
| September 3, 2026 | K260503 | Triton 1 System | Neptune Medical, Inc. | California | Substantially Equivalent | 510(k) traditional | FDF | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260503) |
| September 1, 2026 | K260884 | UNIDRIVE Select System | Karl Storz SE & CO. KG | Germany | Substantially Equivalent | 510(k) traditional | GCJ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260884) |
| August 28, 2026 | K260517 | Automatic Core Biopsy Instrument | Zhejiang Curaway Medical Technology Co., Ltd. | China | Substantially Equivalent | 510(k) traditional | KNW | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260517) |
| August 27, 2026 | K260856 | Disposable Distal Attachment D-201-13404 | Olympus Medical Systems Corporation | Japan | Substantially Equivalent | 510(k) traditional | FDS | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260856) |
| August 27, 2026 | K260824 | Gastrointestinal Videoscope Olympus GIF-2T1500 | Olympus Medical Systems Corporation | Japan | Substantially Equivalent | 510(k) traditional | FDS | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260824) |
| August 26, 2026 | K261153 | LithoVue Elite Digital Flexible Ureteroscope System | Boston Scientific Corporation | Massachusetts | Substantially Equivalent | 510(k) traditional | FGB | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261153) |
| August 26, 2026 | K260972 | OEV-271MUH LCD Monitor;OEV-321MUH LCD Monitor;OEV-431MUH LCD Monitor | Sony Corporation | Japan | Substantially Equivalent | 510(k) traditional | GCJ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260972) |
| August 26, 2026 | K253715 | Edi Catheter ENFit 6Fr/48 cm (6893166); Edi Catheter ENFit 6Fr/49cm (6893273); Edi Catheter ENFit 6Fr/50cm... | Maquet Critical Care AB | Sweden | Substantially Equivalent | 510(k) traditional | PIF | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253715) |
| August 21, 2026 | P240031/S005 | Neuspera Sacral Neuromodulation (SNM) System | Neuspera Medical, Inc. | California | Approved | PMA real-time process supplement | EZW | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P240031S005) |
| August 21, 2026 | K261015 | Solo Scope Colonoscope System | Gi View, Ltd. | Israel | Substantially Equivalent | 510(k) traditional | FDF | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261015) |
| August 20, 2026 | P250018 | RefluxStop® Device and RefluxStop® Deployment Tool | Implantica CE Reflux , Ltd. |  | Approved | PMA original approval | LEI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P250018) |
| August 20, 2026 | DEN250043 | Qoramatic Automated Stool Management | Cm Technologies, Inc. | Texas | Unknown | De Novo | SJB | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=DEN250043) |
| August 19, 2026 | K260799 | Nipro Dry Acid Concentrate Mixer | Nipro Technical Solutions, Incoporated | Arizona | Substantially Equivalent | 510(k) traditional | KPO | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260799) |
| August 14, 2026 | P970004/S456 | InterStim™ Therapy System, Verify™ Evaluation System | Medtronic Neuromodulation | Minnesota | 30-day notice accepted | PMA 30-day notice | EZW | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P970004S456) |
| August 14, 2026 | P240011/S015 | Altaviva™ | Medtronic Neuromodulation | Minnesota | 30-day notice accepted | PMA 30-day notice | QPT | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P240011S015) |
| August 14, 2026 | P080025/S350 | InterStim™ Therapy System, Verify™ Evaluation System | Medtronic Neuromodulation | Minnesota | 30-day notice accepted | PMA 30-day notice | QON | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P080025S350) |
| August 14, 2026 | K262571 | EnCor EnCompass™ Breast Biopsy and Tissue Removal System | Bard Peripheral Vascular, Inc. | Arizona | Substantially Equivalent | 510(k) special | KNW | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262571) |
| August 14, 2026 | K262552 | Single-use Flexible Ureteroscope (Single-use Flexible Ureteroscope: SUV-5C-B) | Scivita Medical Technology Co., Ltd. | China | Substantially Equivalent | 510(k) special | FGB | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262552) |
| August 14, 2026 | K261890 | 52Fr ViSiGi LUX™; 52Fr ViSiGi 3D® | Boehringer Laboratories, LLC | Pennsylvania | Substantially Equivalent | 510(k) special | KNT | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261890) |
| August 13, 2026 | P000006/S076 | Titan Inflatable Penile Prosthesis | Coloplast Corp. | Minnesota | 30-day notice accepted | PMA 30-day notice | FHW | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P000006S076) |
| August 13, 2026 | K261139 | VereSee (VER150, VER200, VER151, VER201, VER200C, and VER-100-103) | Freyja Healthcare, LLC | Massachusetts | Substantially Equivalent | 510(k) traditional | GCJ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261139) |
| August 12, 2026 | K262792 | Brevera Biopsy System with CorLumina Imaging Technology (BREVDISP09) | Hologic, Inc. | Massachusetts | Substantially Equivalent | 510(k) special | KNW | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262792) |
| August 10, 2026 | K254069 | Hemoclip (511 series, 543 series) | Hangzhou AGS MedTech Co., Ltd. | China | Substantially Equivalent | 510(k) traditional | PKL | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254069) |
| August 10, 2026 | K253468 | Nova Eye iTrack™ 250A Canaloplasty Microcatheter (iTrack™ 250A) | Nova Eye, Inc. | California | Substantially Equivalent | 510(k) traditional | MPA | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253468) |
| August 8, 2026 | P970004/S455 | InterStim™ Therapy System, Verify™ Evaluation System | Medtronic Neuromodulation | Minnesota | 30-day notice accepted | PMA 30-day notice | EZW | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P970004S455) |
| August 7, 2026 | P200035/S041 | OrganOx metra System | Organox Limited |  | 30-day notice accepted | PMA 30-day notice | QQK | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P200035S041) |
| August 7, 2026 | P190006/S113 | Axonics Sacral Neuromodulation System | Boston Scientific Corporation | Massachusetts | Approved | PMA 180-day supplement | QON | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P190006S113) |
| August 7, 2026 | P180046/S113 | Axonics Sacral Neuromodulation System | Boston Scientific Corporation | Massachusetts | Approved | PMA 180-day supplement | EZW | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P180046S113) |
| August 7, 2026 | K260567 | EW10-EC02 Endoscopy Support Program | Fujifilm Corporation | Japan | Substantially Equivalent | 510(k) special | QNP | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260567) |
| August 7, 2026 | K253702 | Intuitive Endoluminal Gastrointestinal System (IG1000) | Intuitive Surgical, Inc. | California | Substantially Equivalent | 510(k) traditional | FDS | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253702) |
| August 7, 2026 | K253505 | Zamenix™ P | Roen Surgical, Inc. | South Korea | Substantially Equivalent | 510(k) traditional | FGB | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253505) |
| August 6, 2026 | K253469 | Ritus™ Safety Fistula Cannula with Anti-Reflux Valve 15G x 30mm (1530VSMM); Ritus™ Safety Fistula Cannula... | Mozarc Medical Us, LLC | Massachusetts | Substantially Equivalent | 510(k) traditional | FIE | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253469) |

## Applicants with the most decisions

| Applicant | Decisions | Latest |
| --- | --- | --- |
| Medtronic Neuromodulation | 119 | October 29, 2026 |
| Boston Scientific Corporation | 71 | September 9, 2026 |
| Intuitive Surgical, Inc. | 30 | October 30, 2026 |
| Organox Limited | 23 | October 9, 2026 |
| Olympus Medical Systems Corporation | 16 | August 27, 2026 |
| Fresenius Medical Care Renal Therapies Group, LLC | 15 | October 19, 2026 |
| Coloplast Corp. | 14 | October 28, 2026 |
| Boston Scientific Corp | 14 | September 14, 2026 |
| Olympus Medical Systems Corp. | 12 | September 10, 2026 |
| Karl Storz SE & CO. KG | 11 | September 1, 2026 |
| TransMedics, Inc. | 10 | October 28, 2026 |
| Fujifilm Corporation | 8 | August 7, 2026 |
| Merz North America, Inc. | 8 | June 26, 2026 |
| Traferox Technologies, Inc. | 7 | October 30, 2026 |
| Proverum, Ltd. | 6 | September 24, 2026 |
| Sequana Medical NV | 6 | May 5, 2026 |
| KARL STORZ Endoscopy-America, Inc. | 5 | October 14, 2026 |
| Medibeacon, Inc. | 5 | October 2, 2026 |
| Neuspera Medical, Inc. | 5 | August 21, 2026 |
| Hangzhou AGS MedTech Co., Ltd. | 5 | August 10, 2026 |

## By decision type

| Decision type | Decisions | Latest |
| --- | --- | --- |
| [510(k) traditional](https://specstream.ai/data/fda-clearances/decision/510k-traditional) | 436 | October 30, 2026 |
| [PMA 30-day notice](https://specstream.ai/data/fda-clearances/decision/pma-30-day-notice) | 190 | October 29, 2026 |
| [510(k) special](https://specstream.ai/data/fda-clearances/decision/510k-special) | 62 | October 30, 2026 |
| [PMA 180-day supplement](https://specstream.ai/data/fda-clearances/decision/pma-180-day-supplement) | 50 | October 30, 2026 |
| [PMA real-time process supplement](https://specstream.ai/data/fda-clearances/decision/pma-real-time-process-supplement) | 35 | October 6, 2026 |
| [PMA 135-day supplement](https://specstream.ai/data/fda-clearances/decision/pma-135-day-supplement) | 15 | March 9, 2026 |
| [PMA special supplement](https://specstream.ai/data/fda-clearances/decision/pma-special-supplement) | 11 | October 2, 2026 |
| [PMA original approval](https://specstream.ai/data/fda-clearances/decision/pma-original-approval) | 10 | August 20, 2026 |
| [De Novo](https://specstream.ai/data/fda-clearances/decision/de-novo) | 4 | August 20, 2026 |

## By state or country

| State or country | Decisions | Latest |
| --- | --- | --- |
| [Minnesota](https://specstream.ai/data/fda-clearances/state/minnesota) | 156 | October 29, 2026 |
| [Massachusetts](https://specstream.ai/data/fda-clearances/state/massachusetts) | 134 | October 28, 2026 |
| [China](https://specstream.ai/data/fda-clearances/country/china) | 101 | October 29, 2026 |
| [California](https://specstream.ai/data/fda-clearances/state/california) | 78 | October 30, 2026 |
| [Japan](https://specstream.ai/data/fda-clearances/country/japan) | 43 | September 11, 2026 |
| [Germany](https://specstream.ai/data/fda-clearances/country/germany) | 22 | October 2, 2026 |
| [South Korea](https://specstream.ai/data/fda-clearances/country/south-korea) | 17 | August 7, 2026 |
| [Florida](https://specstream.ai/data/fda-clearances/state/florida) | 16 | October 30, 2026 |
| [Illinois](https://specstream.ai/data/fda-clearances/state/illinois) | 16 | July 15, 2026 |
| [United Kingdom](https://specstream.ai/data/fda-clearances/country/united-kingdom) | 11 | September 12, 2026 |
| [Israel](https://specstream.ai/data/fda-clearances/country/israel) | 11 | August 21, 2026 |
| [Pennsylvania](https://specstream.ai/data/fda-clearances/state/pennsylvania) | 10 | September 10, 2026 |
| [Ohio](https://specstream.ai/data/fda-clearances/state/ohio) | 9 | October 20, 2026 |
| [Canada](https://specstream.ai/data/fda-clearances/country/canada) | 9 | September 30, 2026 |
| [Sweden](https://specstream.ai/data/fda-clearances/country/sweden) | 8 | August 26, 2026 |
| [Texas](https://specstream.ai/data/fda-clearances/state/texas) | 8 | August 20, 2026 |
| [Wisconsin](https://specstream.ai/data/fda-clearances/state/wisconsin) | 8 | June 26, 2026 |
| [New York](https://specstream.ai/data/fda-clearances/state/new-york) | 8 | June 16, 2026 |
| [Arizona](https://specstream.ai/data/fda-clearances/state/arizona) | 7 | August 19, 2026 |
| [Taiwan](https://specstream.ai/data/fda-clearances/country/taiwan) | 7 | June 10, 2026 |
| [North Carolina](https://specstream.ai/data/fda-clearances/state/north-carolina) | 6 | October 27, 2026 |
| [Maryland](https://specstream.ai/data/fda-clearances/state/maryland) | 6 | October 16, 2026 |
| [Georgia](https://specstream.ai/data/fda-clearances/state/georgia) | 6 | July 10, 2026 |
| [Missouri](https://specstream.ai/data/fda-clearances/state/missouri) | 5 | October 2, 2026 |
| [Ireland](https://specstream.ai/data/fda-clearances/country/ireland) | 5 | September 23, 2026 |

## Where FDA publishes these decisions

- [FDA 510(k) database](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm)
- [FDA PMA database](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm)
- [openFDA device API](https://open.fda.gov/apis/device/)

Source: [openFDA device 510(k) and PMA (U.S. Food and Drug Administration)](https://open.fda.gov/apis/device/). CC0 1.0 (openFDA). Decisions are as FDA publishes them in its 510(k) and PMA databases, read through openFDA. A PMA row is the original approval or one supplement. The panel is the FDA advisory committee that reviewed the device. FDA adds decisions to openFDA some weeks after their date, so the newest weeks fill in later. The 510(k) contact is in the full list only, as FDA prints it for the submission.

Free to reuse with credit to SpecStream under [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/).