# Schoelly Fiberoptic GmbH

- Location (FDA's records): Denzlingen, DE
- FDA decisions: 12 (1999–2024): 12 510(k) clearances
- Product codes: EOB (3), GCJ (3), HIH (2), FGA (1), FET (1), HET (1), EIA (1)
- 510(k) review time since 2016: median 266 days, against 100 for FDA's reviews in the same codes and years (1 of 4 faster)
- Predicates its devices cite: 14 (3 its own); citations of its devices by later devices: 12 (3 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Schoelly Imaging, Inc.: 2 (https://510kreport.com/company/schoelly-imaging)
- Richard Wolf Medical Instruments Corp.: 1 (https://510kreport.com/company/richard-wolf-medical-instruments)
- KARL STORZ Endoscopy-America, Inc.: 1 (https://510kreport.com/company/karl-storz-endoscopy-america)
- Fiber Imaging Technologies, Inc.: 1 (https://510kreport.com/company/fiber-imaging-technologies)
- Olympus America, Inc.: 1 (https://510kreport.com/company/olympus-america)
- Olympus Medical Systems Corp.: 1 (https://510kreport.com/company/olympus-medical-systems)
- Stryker Endoscopy: 1 (https://510kreport.com/company/stryker-endoscopy)
- Stryker Corp.: 1 (https://510kreport.com/company/stryker)

## Firms that cite its devices most
- Well Lead Medical Co., Ltd.: 2 (https://510kreport.com/company/well-lead-medical)
- Stryker Corp.: 1 (https://510kreport.com/company/stryker)
- CooperSurgical, Inc.: 1 (https://510kreport.com/company/coopersurgical)
- Atmos Medizintechnik GmbH & Co. KG: 1 (https://510kreport.com/company/atmos-medizintechnik)
- Solace Therapeutics: 1 (https://510kreport.com/company/solace-therapeutics)
- Miras Mirror Imaging Solutions, Ltd.: 1 (https://510kreport.com/company/miras-mirror-imaging-solutions)
- American Medical Endoscopy, Inc.: 1 (https://510kreport.com/company/american-medical-endoscopy)
- H&A Mui Enterprises, Inc.: 1 (https://510kreport.com/company/h-a-mui-enterprises)

## Its most-cited devices
- K150158: Schoelly Cystoscopes/Hysteroscopes and Accessories (2015), cited by 5
- K132009: Cmos Video Nasopharyngoscope System (2014), cited by 2
- K151308: Schoelly Nephroscope Set, Schoelly Ultra-Mini Nephroscope Set (2016), cited by 1
- K221591: Camera System (Camera Control Unit, Camera Head to be coupled to a fiberoptic scope), NIR FI Light Source (2023), cited by 1
- K143673: CMOS Video Nasopharyngoscope System (2015), cited by 1
- K984641: Flexiscope Optomodul (1999), cited by 1

## Recent decisions
- K233225: SCHOELLY Oxygen Saturation Imaging (OSI) Camera System (Camera Control Unit, Camera Head to be coupled to a fiberoptic scope) (Jun 20, 2024)
- K221591: Camera System (Camera Control Unit, Camera Head to be coupled to a fiberoptic scope), NIR FI Light Source (Feb 23, 2023)
- K201617: TipVision Videoscope System (TipVision VideoScope 0°/30°; EleVision HD 2 Camera Control Unit (CCU)) (Mar 12, 2021)
- K201970: Schoelly Cystoscopes/Hysteroscopes and Accessories (Oct 8, 2020)
- K151308: Schoelly Nephroscope Set, Schoelly Ultra-Mini Nephroscope Set (Feb 9, 2016)
- K150158: Schoelly Cystoscopes/Hysteroscopes and Accessories (Mar 9, 2015)
- K143673: CMOS Video Nasopharyngoscope System (Mar 4, 2015)
- K142249: Schoelly Sinuscope (Jan 27, 2015)

Source page: https://510kreport.com/company/schoelly-fiberoptic