Data / Medical devices / United States / United States Endoscopy Group, Inc.
United States Endoscopy Group, Inc.: FDA-registered device maker in Mentor, OH, United States, 73 510(k) clearances
United States Endoscopy Group, Inc. is registered with the FDA (registration 1528319) in Mentor, OH, United States. It lists 51 device types. The FDA files 73 510(k) clearances under its listings, the newest dated April 18, 2025. 10 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 3, 2026.
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- FDA registration number
- 1528319
- FEI number
- 1000122656
- Address
- 5976 Heisley Rd, Mentor, OH, United States, 44060
- Owner or operator
- STERIS Corporation (10078069)
- Roles
- Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- October 9, 2020
- Registered through
- 2027
- Brand names listed
- 16 Fr CDT 5 Pack (2000181) (EN-SD), 16 Fr CryoDecompression Tube (CDT) 5 Pack (2000181) (EN-SD), 20 Fr CDT 5 Pack (ACCCC3CDT05) (EN-SD), 3E-ZYME Triple Enzyme Cleaning Solution (SL-CFE), 5085 Harmony Table Pads (MG-RR), ADVANCE CAPSULE DELIVERY DEVICE (00711144) (EN-MF), ARCH Orthopedic Leg Positioner (MG-RR), Active Venting Spray Kit, 16 Fr CDT (2000516) (EN-SD) and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| April 18, 2025 | K250842 | PADLOCK CLIP EFTR Kit (00713229) | PKL | Substantially Equivalent | STERIS Corporation | accessdata.fda.gov |
| December 20, 2024 | K241888 | Single-use Balloon Dilatation Catheter | FGE | Substantially Equivalent | Leo Medical Co., Ltd. | accessdata.fda.gov |
| October 11, 2024 | K242742 | DEFENDO Single Use Valve Kit AW/S Valves - 2pc for OLYMPUS EUS (00711900) | ODC | Substantially Equivalent | STERIS Corporation | accessdata.fda.gov |
| September 17, 2024 | K240274 | PADLOCK CLIP EFTR Kit (00713229) | PKL | Substantially Equivalent | STERIS Corporation | accessdata.fda.gov |
| July 3, 2024 | K241591 | Blue Eye | PLL | Substantially Equivalent | The Standard Co., Ltd. | accessdata.fda.gov |
| March 8, 2024 | K232826 | Articulator Injection Needle (00711807), Articulator Injection Needle (00711810), Articulator Injection Needle - enteroscope (00711808), Carr-Locke Injection Needle (00711811), Carr-Locke Injection Needle (00711812), Carr-Locke Injection Needle (00711813), Carr-Locke Injection Needle (00711814), Carr-Locke Injection Needle (00711822), Carr-Locke Injection Needle (00711823), Carr-Locke Injection Needle (00711824) | FBK | Substantially Equivalent | Steris | accessdata.fda.gov |
| February 9, 2024 | K240098 | DEFENDO Single Use Valve Kit AW/S Valves - 2pc for OLYMPUS EUS (00711900) | ODC | Substantially Equivalent | STERIS Corporation | accessdata.fda.gov |
| December 21, 2023 | K232329 | Defendo Fujifilm 700 Single Use Biopsy Valve; Defendo Fujifilm 700 Single Use Air/Water Valve; Defendo Fujifilm 700 Single Use Suction Valve; ENDOGATOR Fujifilm 700 Single Use Connector; Defendo Fujifilm 700 Single Use Cleaning Adapter | ODC | Substantially Equivalent | Medivators (A Subsidiary of Steris Corporation) | accessdata.fda.gov |
| October 20, 2023 | K232951 | BioShield Biopsy Valve (00711124); BioShield Biopsy Valve (00711125); BioShield Biopsy Valve (00711126); BioShield Biopsy Valve (00711127); BioShield Biopsy Valve (00711129); BioShield Biopsy Valve (00711135); BioShield Biopsy Valve (00711136); BioShield Biopsy Valve - sterile (00711128); BioShield Irrigator (00711133); BioShield Irrigator (00711137); BioShield Irrigating Adaptor (00711131); BioShield Irrigator - extension tubing (00711134) | ODC | Substantially Equivalent | Steris | accessdata.fda.gov |
| October 16, 2023 | K232118 | ANDORATE® Valve Kit | ODC | Substantially Equivalent | Ga Health Company Limited | accessdata.fda.gov |
| December 2, 2022 | K223369 | truFreeze Console, PN CC301; Aire PV Passive Venting Catheter, PN CO840703; 16 Fr CDT 5 Pack, PN 2000181; 20Fr CDT 5 Pack, PN ACCCC3CDT05; Active Venting Spray Kit, 20 Fr CDT, PN 2000177; Active Venting Spray Kit 16 Fr CDT, PN 20000516; Rapid AV Catheter 5 Pack, PN 2000184 | GEH | Substantially Equivalent | STERIS Corporation | accessdata.fda.gov |
| August 18, 2022 | K222272 | truFreeze Console, PN CC301; Aire PV Passive Venting Catheter, PN CO840703; 16 Fr CDT 5 Pack, PN 2000181; 20Fr CDT 5 Pack, PN ACCCC3CDT05; Active Venting Spray Kit, 20 Fr CDT, PN 2000177; Active Venting Spray Kit 16 Fr CDT, PN 20000516; Rapid AV Catheter 5 Pack, PN 2000184 | GEH | Substantially Equivalent | STERIS Corporation | accessdata.fda.gov |
| August 12, 2022 | K220434 | Blue Eye (TS-905) | PLL | Substantially Equivalent | The Standard Co., Ltd. | accessdata.fda.gov |
| March 3, 2022 | K211787 | Hemoclip | PKL | Substantially Equivalent | Hangzhou AGS MedTech Co., Ltd. | accessdata.fda.gov |
| February 23, 2022 | K212668 | Sclerotherapy Needle | FBK | Substantially Equivalent | Zhejiang Chuangxiang Medical Technology Co., Ltd. | accessdata.fda.gov |
| October 7, 2021 | K212860 | SmartBand EMR Kit (SB-EMR-K, SB-EMR-K-12, SB-EMR-K-9.4), SmartBand EMR Pack (SB-EMR-P, SB-EMR-P-12, SB-EMR-P-9.4), SmartSnare EMR Hexagonal Snare (SS-230-1 or packaged with kit) | FDI | Substantially Equivalent | STERIS Corporation | accessdata.fda.gov |
| September 3, 2021 | K210342 | BioShield- ERCP Biopsy Valve, BioShield Irrigator - Extension Tubing, BioShield Irrigating Adaptor | ODC | Substantially Equivalent | STERIS Corporation | accessdata.fda.gov |
| January 14, 2021 | K202104 | BioGuard EUS Air/Water and Suction Valves | ODC | Substantially Equivalent | STERIS Corporation | accessdata.fda.gov |
| January 8, 2021 | K203630 | BioGuard Air/Water and Suction Valves | ODC | Substantially Equivalent | Steris Corporations | accessdata.fda.gov |
| December 7, 2020 | K201183 | Vortex Radial Spray Catheter | GEH | Substantially Equivalent | CSA Medical, Inc. | accessdata.fda.gov |
| November 6, 2020 | K202583 | BioShield biopsy valve EUS - Linear | ODD | Substantially Equivalent | STERIS Corporation | accessdata.fda.gov |
| June 18, 2020 | K200481 | Andorate Biopsy Valve, Andorate Biopsy Irrigator | ODC | Substantially Equivalent | Ga Health Company Limited | accessdata.fda.gov |
| May 21, 2020 | K192265 | gi-4000 Electrosurgical Generator | GEI | Substantially Equivalent | United States Endoscopy Group, Inc. | accessdata.fda.gov |
| April 21, 2020 | K200745 | Lariat, Hot/Cold Snare | FDI | Substantially Equivalent | United States Endoscopy Group, Inc. | accessdata.fda.gov |
| January 27, 2020 | K191715 | Endoscope Tip Protector - Sterile, Endoscope Tip Protector - Non-sterile | OCU | Substantially Equivalent | STERIS Corporation | accessdata.fda.gov |
| October 25, 2019 | K192518 | Reusable Monopolar Active Cord | GEI | Substantially Equivalent | Us Endoscopy | accessdata.fda.gov |
| October 24, 2019 | K192722 | Padlock Clip defect closure system, Padlock Pro-Select defect closure device | PKL | Substantially Equivalent | STERIS Corporation | accessdata.fda.gov |
| September 17, 2019 | K192059 | Bio Guard Air/Water & Suction Valves | ODC | Substantially Equivalent | United States Endoscopy Group, Inc. | accessdata.fda.gov |
| September 6, 2019 | K191366 | Vacutore Air/Water Bottle Tubing | OCX | Substantially Equivalent | Smartdata Suzhou Co., Ltd. | accessdata.fda.gov |
| August 1, 2019 | K191559 | AquaShield System CO2, AquaShield System CO2-PENTAX, AquaShield System CO2-FUJIFILM | FEQ | Substantially Equivalent | United States Endoscopy Group, Inc. | accessdata.fda.gov |
| November 21, 2018 | K182909 | Roth Net Retriever Product Line | FDI | Substantially Equivalent | United States Endoscopy Group, Inc. | accessdata.fda.gov |
| September 21, 2018 | K182258 | AquaShield System CO2 ; AquaShield System CO2 - PENTAX ; AquaShield System CO2 - Fujifilm | FEQ | Substantially Equivalent | United States Endoscopy Group, Inc. | accessdata.fda.gov |
| July 6, 2018 | K181509 | Endorate Valve Sets | OCX | Substantially Equivalent | Smartdata Suzhou Co., Ltd. | accessdata.fda.gov |
| May 21, 2018 | K172729 | Polypectomy Snare | FDI | Substantially Equivalent | Hangzhou AGS MedTech Co., Ltd. | accessdata.fda.gov |
| April 19, 2018 | K180731 | Ultramatrix EUS Balloon | ODG | Substantially Equivalent | United States Endoscopy Group, Inc. (Us Endoscopy) | accessdata.fda.gov |
| April 16, 2018 | K172727 | Hemoclip | PKL | Substantially Equivalent | Hangzhou AGS MedTech Co., Ltd. | accessdata.fda.gov |
| April 12, 2018 | K180689 | Padlock Clip defect closure device; Padlock Clip Pro-Select defect closure device | PKL | Substantially Equivalent | STERIS Corporation | accessdata.fda.gov |
| October 23, 2017 | K172805 | gi-4000 Electrosurgical Generator | GEI | Substantially Equivalent | United States Endoscopy Group, Inc. | accessdata.fda.gov |
| August 30, 2017 | K171626 | truFreeze System | GEH | Substantially Equivalent | CSA Medical, Inc. | accessdata.fda.gov |
| March 10, 2017 | K163495 | AdvanCE capsule endoscope delivery device | NEZ | Substantially Equivalent | United States Endoscopy Group, Inc. | accessdata.fda.gov |
| January 6, 2017 | K163492 | Oracle EUS Balloon; Oracle EUS latex balloon - Olympus Radial; Oracle EUS latex balloon - Olympus Linear; Oracle EUS latex balloon - Fujinon Radial; Oracle EUS latex balloon - Fujinon Linear | FDF | Substantially Equivalent | United States Endoscopy Group, Inc. | accessdata.fda.gov |
| January 4, 2017 | K163424 | AquaShield System - PENTAX, AquaShield System CO2 - PENTAX, AquaShield System CO2 - FUJINON | FEQ | Substantially Equivalent | United State Endoscopy Group, Inc. | accessdata.fda.gov |
| October 15, 2015 | K152035 | iSnare system-Lariat | FBK | Substantially Equivalent | United States Endoscopy Group, Inc. | accessdata.fda.gov |
| July 30, 2015 | K151889 | Infinity ERCP Sampling Device | FDX | Substantially Equivalent | United States Endoscopy Group, Inc. | accessdata.fda.gov |
| July 6, 2015 | K151197 | Lariat snare | FDI | Substantially Equivalent | United States Endoscopy Group, Inc. | accessdata.fda.gov |
| April 24, 2014 | K140763 | MONOFILAMENT POLYPECTOMY SNARE | FDI | Substantially Equivalent | United States Endoscopy | accessdata.fda.gov |
| April 4, 2014 | K140315 | US ENDOSCOPY DISTAL ATTACHMENT CAP | OCX | Substantially Equivalent | United States Endoscopy Group, Inc. | accessdata.fda.gov |
| March 12, 2014 | K140405 | TORRENT IRRIGATION SYSTEM | OCX | Substantially Equivalent | United States Endoscopy Group, Inc. | accessdata.fda.gov |
| September 26, 2013 | K130983 | GENII ARC SMART ARGON PROBE | GEI | Substantially Equivalent | Genii, Inc. | accessdata.fda.gov |
| August 6, 2013 | K123047 | BRACCO DIAGNOSTICS INC. CO2 ENDOSCOPIC INSUFFLATOR IN LINE TUBING SET | FCX | Substantially Equivalent | Bracco Diagnostic, Inc. | accessdata.fda.gov |
| September 11, 2012 | K122462 | ROTH NET RETRIEVER | FDI | Substantially Equivalent | United States Endoscopy Group, Inc. | accessdata.fda.gov |
| September 6, 2012 | K120814 | PADLOCK CLIP-12 | PKL | Substantially Equivalent | Aponos Medical Corp. | accessdata.fda.gov |
| May 30, 2012 | K120084 | ENDOSCOPIC RETRIEVAL DEVICE | OCZ | Substantially Equivalent | United States Endoscopy Group, Inc. | accessdata.fda.gov |
| March 22, 2012 | K113265 | GENII GI 4000 ELECTROSUGICAL GENERATOR | GEI | Substantially Equivalent | Genii, Inc. | accessdata.fda.gov |
| November 3, 2011 | K111648 | BRACCO DIAGNOSTICS, INC. CO2MPACT ENDODCOPIC INSUFFLATOR | FCX | Substantially Equivalent | Bracco Diagnostic, Inc. | accessdata.fda.gov |
| November 1, 2011 | K111028 | EUS BALLOON | FDF | Substantially Equivalent | United States Endoscopy Group, Inc. | accessdata.fda.gov |
| December 30, 2010 | K103239 | IRRIGATION SYSTEM | OCX | Substantially Equivalent | United States Endoscopy Group, Inc. | accessdata.fda.gov |
| September 7, 2010 | K102273 | MERIT BIPOLAR COAGULATION PROBE | KNS | Substantially Equivalent | Merit Medical Systems, Inc. | accessdata.fda.gov |
| August 2, 2010 | K093079 | TOUCHSOFT COAGULATOR WITH BANANA FITTING, MODEL 4581 AND WITH UNIVERSAL FITTING, MODEL 4581-U | KNS | Substantially Equivalent | Hobbs Medical, Inc. | accessdata.fda.gov |
| July 16, 2010 | K101146 | WATER BOTTLE CAP SYSTEM | FEQ | Substantially Equivalent | United States Endoscopy Group, Inc. | accessdata.fda.gov |
| March 19, 2007 | K070420 | BIOSHIELD-ERCP BIOPSY VALVE, MODEL 00711138 | ODD | Substantially Equivalent | United States Endoscopy Group, Inc. | accessdata.fda.gov |
| December 27, 2005 | K053008 | E-Z-EM ENDOSCOPIC CO2 REGULATOR | FCX | Substantially Equivalent | E-Z-Em, Inc. | accessdata.fda.gov |
| July 11, 2005 | K051068 | ZUTRON COLONOSCOPE STIFFENING DEVICE | FDF | Substantially Equivalent | Zutron Medical | accessdata.fda.gov |
| July 8, 2004 | K040961 | INJECTOR NEEDLE/SNARE | FDI | Substantially Equivalent | United States Endoscopy Group, Inc. | accessdata.fda.gov |
| June 10, 2004 | K040836 | DISPOSABLE OVERTUBE | FED | Substantially Equivalent | United States Endoscopy Group, Inc. | accessdata.fda.gov |
| June 20, 1997 | K971842 | COAXIAL NEEDLE | FCG | Substantially Equivalent | United States Endoscopy Group, Inc. | accessdata.fda.gov |
| October 4, 1996 | K962676 | DISPOSABLE ENDOSCOPIC RETRIEVAL DEVICE | FGO | Substantially Equivalent | United States Endoscopy Group, Inc. | accessdata.fda.gov |
| April 6, 1995 | K951104 | ENDOBOOT | OCU | Substantially Equivalent | United States Endoscopy Group, Inc. | accessdata.fda.gov |
| March 29, 1993 | K925361 | BIOPSY FORCEPS, ELECTRIC | KGE | Substantially Equivalent | United States Endoscopy Group, Inc. | accessdata.fda.gov |
| November 24, 1992 | K924106 | BIOPSY FORCEPS | KNW | Substantially Equivalent | United States Endoscopy Group, Inc. | accessdata.fda.gov |
| November 24, 1992 | K924105 | SNARE FLEXIBLE | FDI | Substantially Equivalent | United States Endoscopy Group, Inc. | accessdata.fda.gov |
| November 24, 1992 | K924104 | CYTOLOGY BRUSH | FDX | Substantially Equivalent | United States Endoscopy Group, Inc. | accessdata.fda.gov |
| October 31, 1988 | K882048 | MEDITRON ENDOLAV MODEL EL-100 | KNS | Substantially Equivalent | Xylog Corp. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| February 4, 2019 | 82142 | Class II | Terminated | US Endoscopy Padlock Clip defect closure system Ref: C910001 The Padlock Clip is indicated for use in flexible endoscopy and for the compression of tissue in the gastrointestinal tract, for hemostasis or for treating les | Potential esophageal laceration during a patient procedure | accessdata.fda.gov |
| December 13, 2016 | 76153 | Class III | Terminated | Roth Net Polyp Retrieval | The firm was notified that the expiration date on the outer carton is different than the expiration date on the inner package. The expiration date is shorter than the actual expiration. | accessdata.fda.gov |
| May 18, 2016 | 74590 | Class II | Terminated | Vari-Safe Injection Needle US endoscopy 5976 Heisley Road Mentor, Ohio 44060 A sterile, single use, flexible sheath device intended to be used for the injection of various types of media through flexible endoscopes | US Endoscopy is conducting a voluntary product recall of one lot of the Vari-Safe Injection Needle as it was identified that the lot was incorrectly distributed. The lot was assembled with internal catheter components which differ from the original Vari-Safe needle internal catheter components. All components are dimensionally similar to the original Vari-Sa | accessdata.fda.gov |
| July 14, 2015 | 71987 | Class II | Terminated | Histolock Resection Device, US Endoscopy. An electrosurgical device designed to be used to endoscopically grasp, dissect and transect tissue during gastrointestinal endoscopic procedures. | The company has determined the sterility cannot be assured for the affected lot. | accessdata.fda.gov |
| March 10, 2015 | 70872 | Class II | Terminated | Talon Grasping Device, 160 cm, US endoscopy. Used for retrieval of foreign bodies, tissue specimens, stones or calculi in endoscopic procedures of the gastrointestinal tract. | A wire component on the distal grasping assembly of the device became detached.. | accessdata.fda.gov |
| February 17, 2015 | 71336 | Class II | Terminated | Velocity" Biopsy Valve, 25 units per box, Product Usage: The disposable Velocity biopsy valve is used to cover the opening of the biopsy inlet port of a flexible gastrointestinal endoscope. The Velocity biopsy valve prov | The company has received reports of structural non conformance at the connection between the valve body and the irrigation tube, resulting in separation of the components during use. | accessdata.fda.gov |
| October 31, 2014 | 69809 | Class II | Terminated | UroSeal Adjustable Endoscopic Valve. Model/Catalog # 00913410 The primary packaging is a Tyvek pouch. The secondary package is a corrugate box. 5 units per box. Used to cover the opening to the biopsy/suction channel of | Packaging non-conformance related to the integrity of the sterile pouch seal. | accessdata.fda.gov |
| March 7, 2013 | 64853 | Class II | Terminated | Torrent" irrigation tubing. Product Usage: The Torrent irrigation system (tubing and accessories to accommodate various endoscopes and irrigation pumps) is intended to provide irrigation via irrigation fluids, such as st | The firm was notified by their customers that there was a water leakage from the white tubing connector. | accessdata.fda.gov |
| December 22, 2011 | 63047 | Class II | Terminated | Infinity sampling device, Cytology Brush, United States Endoscopy Group, Inc., 5976 Heisley Road, Mentor, OH 44060 The Infinity sampling device is a disposable cytology brush used to retrieve cytological cell samples in | US Endoscopy received five complaints which noted difficulty in deploying the cytology brush through the catheter. | accessdata.fda.gov |
| November 14, 2011 | 63196 | Class II | Terminated | Endoscopic retrieval device. The disposable Raptor grasping device in intended to retrieve foreign bodies or resected tissue specimens in endoscopic procedures of the upper and lower gastrointestinal tract or biliary tra | When the outer catheter is either coiled or in a contorted configuration outside of the endoscope and the patient, and excessive force is applied to the handle, the jaws may become inoperable and may become stuck in the open condition. | accessdata.fda.gov |
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Updated April 18, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.