Data / Medical devices / Germany / Schoelly Fiberoptic, GMBH
Schoelly Fiberoptic, GMBH: FDA-registered device maker in DENZLINGEN Baden-Wurttemberg, Germany, 12 510(k) clearances
Schoelly Fiberoptic, GMBH is registered with the FDA (registration 8043903) in DENZLINGEN Baden-Wurttemberg, Germany. It lists 21 device types. The FDA files 12 510(k) clearances under its listings, the newest dated June 20, 2024. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 8043903
- FEI number
- 3002808088
- Address
- Robert-Bosch-Str. 1-3, DENZLINGEN Baden-Wurttemberg, Germany, 79211
- Owner or operator
- SCHOELLY FIBEROPTIC, GMBH (9004385)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- March 10, 2008
- Registered through
- 2026
- Brand names listed
- 2D NIR FI Laparoscopes, Arthroscopes, Cystoscopes, Endoscopic Camera Control Unit, Endoscopic Camera Heads, Hysteroscopes, LED Light Sources, Laparoscopes 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 |
|---|---|---|---|---|---|---|
| June 20, 2024 | K233225 | SCHOELLY Oxygen Saturation Imaging (OSI) Camera System (Camera Control Unit, Camera Head to be coupled to a fiberoptic scope) | GCJ | Substantially Equivalent | Schoelly Fiberoptic GmbH | accessdata.fda.gov |
| February 23, 2023 | K221591 | Camera System (Camera Control Unit, Camera Head to be coupled to a fiberoptic scope), NIR FI Light Source | GCJ | Substantially Equivalent | Schoelly Fiberoptic GmbH | accessdata.fda.gov |
| March 12, 2021 | K201617 | TipVision Videoscope System (TipVision VideoScope 0°/30°; EleVision HD 2 Camera Control Unit (CCU)) | HET | Substantially Equivalent | Schoelly Fiberoptic GmbH | accessdata.fda.gov |
| October 8, 2020 | K201970 | Schoelly Cystoscopes/Hysteroscopes and Accessories | HIH | Substantially Equivalent | Schoelly Fiberoptic GmbH | accessdata.fda.gov |
| February 9, 2016 | K151308 | Schoelly Nephroscope Set, Schoelly Ultra-Mini Nephroscope Set | FGA | Substantially Equivalent | Schoelly Fiberoptic GmbH | accessdata.fda.gov |
| March 9, 2015 | K150158 | Schoelly Cystoscopes/Hysteroscopes and Accessories | HIH | Substantially Equivalent | Schoelly Fiberoptic GmbH | accessdata.fda.gov |
| March 4, 2015 | K143673 | CMOS Video Nasopharyngoscope System | EOB | Substantially Equivalent | Schoelly Fiberoptic GmbH | accessdata.fda.gov |
| January 27, 2015 | K142249 | SCHOELLY SINUSCOPE | EOB | Substantially Equivalent | Schoelly Fiberoptic GmbH | accessdata.fda.gov |
| December 5, 2014 | K143221 | Schoelly Laparoscope | GCJ | Substantially Equivalent | Schoelly Fiberoptic GmbH | accessdata.fda.gov |
| June 2, 2014 | K133682 | SCHOELLY ARTHROSCOPE | HRX | Substantially Equivalent | Scholly Fiberoptic GmbH | accessdata.fda.gov |
| January 16, 2009 | K083553 | NASO-LARYNGO-PHARYNGOSCOPE | EOB | Substantially Equivalent | Schoelly Imaging, Inc. | accessdata.fda.gov |
| October 13, 1999 | K992527 | URETERO-RENOSCOPE | FGB | Substantially Equivalent | Fiber Imaging Technologies, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| June 23, 2023 | 92700 | Class II | Ongoing | UroLift Visual Obturator, 20Ch-The visual obturator is used with the UroLift system. Instrument for insertion of a cystoscope shaft into the bladder. Model: UL-VO | There is an improperly performed weld between the cone of the sheath lock and tube of the obturator; mechanical load capacity is impaired, and fracture of the welded joint may occur. Contamination can occur in this capillary gap, which is not covered by the reprocessing validations performed. | accessdata.fda.gov |
Compare with other makers
- All makers of Nasopharyngoscope (Flexible Or Rigid)
- All makers of Laparoscope, General & Plastic Surgery
- All makers of Endoscopic Video Imaging System/Component, Gastroenterology-Urology
- All makers of Cystoscope And Accessories, Flexible/Rigid
- All makers of Hysteroscope (And Accessories)
- All makers of Laparoscope, Gynecologic (And Accessories)
Updated June 20, 2024. 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.