# Richard Wolf Medical Instruments Corp.

- Location (FDA's records): Vernon Hills, IL
- FDA decisions: 155 (1977–2024): 153 510(k) clearances and 2 original PMA approvals
- Names in FDA's records: Richard Wolf Medical Instruments Corp. (144); Richard Wolf Medical Instruments Corporation (11)
- Product codes: GCJ (28), HRX (14), GEI (13), HET (9), FET (8), HIF (7), HIH (6), FGB (5), GCT (4), FFK (4), HWE (3), GWG (3)
- 510(k) review time since 2016: median 115 days, against 106 for FDA's reviews in the same codes and years (2 of 7 faster)
- Predicates its devices cite: 126 (80 its own); citations of its devices by later devices: 144 (80 its own)
- Recalls linked to its devices: 16 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- KARL STORZ Endoscopy-America, Inc.: 8 (https://510kreport.com/company/karl-storz-endoscopy-america)
- Richard Wolf GmbH: 2 (https://510kreport.com/company/richard-wolf)
- Pentax Precision Instrument Corp.: 2 (https://510kreport.com/company/pentax-precision-instrument)
- Applied Medical Resources: 2 (https://510kreport.com/company/applied-medical-resources)
- Wells Johnson Co.: 2 (https://510kreport.com/company/wells-johnson)
- Trimedyne, Inc.: 2 (https://510kreport.com/company/trimedyne)
- Acmi Corporation: 2 (https://510kreport.com/company/acmi)
- Stryker Endoscopy: 1 (https://510kreport.com/company/stryker-endoscopy)

## Firms that cite its devices most
- Trokamed GmbH: 4 (https://510kreport.com/company/trokamed)
- Netoptix Corp.: 4 (https://510kreport.com/company/netoptix)
- Corinth Medtech, Inc.: 4 (https://510kreport.com/company/corinth-medtech)
- Contec Medical Vision, Ltd.: 4 (https://510kreport.com/company/contec-medical-vision)
- Spine View, Inc.: 3 (https://510kreport.com/company/spine-view)
- Innovative Endoscopy Components, LLC: 3 (https://510kreport.com/company/innovative-endoscopy-components)
- Olympus Winter & Ibe GmbH: 2 (https://510kreport.com/company/olympus-winter-ibe)
- Xomed, Inc.: 2 (https://510kreport.com/company/xomed)

## Its most-cited devices
- K973405: Yeung Endoscopic Spine System (1998), cited by 6
- K880314: Hysteroscope Autonom 4992 (1988), cited by 5
- K980302: Working Elements, Resectoscope Sheaths, Electrodes, Obturators, Endoscopes (1998), cited by 4
- K970088: Riwo Drive with Footswitch/Motor Handle, Coomplete,6000RPM/3000RPM/Rotary Blades and Abraders See Section 1: (1997), cited by 4
- K950502: CCD Endocam 5501 (1995), cited by 4
- K023659: 1-CCD Endocam 5520 System (2003), cited by 4

## Recent decisions
- K231291: Perforated Baskets (Jun 3, 2024)
- K230194: HF Surgery Generator 400KHZ (Mar 22, 2023)
- K212808: Logic Hd camera head green, System green (Jun 14, 2022)
- K211332: D Camera Controller (Oct 1, 2021)
- K203226: Telescope 0 O 10MM WL 305MM / Telescope 30 O 10MM WL 305MM / Telescope 50 O 10MM WL 305MM, Telescope 0 O 10MM WL 440MM / Telescope 30 O 10MM WL 440MM / Telescope 50 O 10MM WL 440MM (May 14, 2021)
- K201897: Sensor-Ureterorenoscope 9 FR WL 600 MM (short RIWO D-URS), Adapter For Controller 5525 (Jan 15, 2021)
- K200617: Logic HD Camera Controller, Logic HD Lite Camera Controller, Logic 4K Camera Contoller, Adapter for Controller 5525 (Jun 23, 2020)
- K183188: Flexible Sensor-Ureterorenoscopes BOA Vision EF, Flexible Sensor-Ureterorenoscopes COBRA Vision EF (May 3, 2019)

Source page: https://510kreport.com/company/richard-wolf-medical-instruments