# Olympus Winter & Ibe GmbH

- Location (FDA's records): Hamburg, DE
- FDA decisions: 43 (1997–2026): 43 510(k) clearances
- Product codes: GEI (13), FAS (6), KCT (4), GCJ (2), NTN (2), FGB (2), HBI (1), KGE (1), NWB (1), HRX (1), FDC (1), JOS (1)
- 510(k) review time since 2016: median 89 days, against 111 for FDA's reviews in the same codes and years (8 of 16 faster)
- Predicates its devices cite: 76 (17 its own); citations of its devices by later devices: 43 (17 its own)
- Recalls linked to its devices: 11 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Olympus America, Inc.: 15 (https://510kreport.com/company/olympus-america)
- Olympus Corp.: 10 (https://510kreport.com/company/olympus)
- Erbe USA, Inc.: 5 (https://510kreport.com/company/erbe-usa)
- Gyrus Acmi, Inc.: 4 (https://510kreport.com/company/gyrus-acmi)
- Olympus Optical Co., Ltd.: 3 (https://510kreport.com/company/olympus-optical)
- Covidien: 2 (https://510kreport.com/company/covidien)
- Olympus Medical Systems Corp.: 2 (https://510kreport.com/company/olympus-medical-systems)
- Celon AG Medical Instruments: 2 (https://510kreport.com/company/celon-ag-medical-instruments)

## Firms that cite its devices most
- Olympus Medical Systems Corp.: 7 (https://510kreport.com/company/olympus-medical-systems)
- Gyrus Acmi, Inc.: 3 (https://510kreport.com/company/gyrus-acmi)
- Cook Ireland, Ltd.: 2 (https://510kreport.com/company/cook-ireland)
- Roei Medical Technologies, Ltd.: 1 (https://510kreport.com/company/roei-medical-technologies)
- Ace Medical Devices Pvt., Ltd.: 1 (https://510kreport.com/company/ace-medical-devices-pvt)
- Intuitive Surgical, Inc.: 1 (https://510kreport.com/company/intuitive-surgical)
- Dornier Medtech America, Inc.: 1 (https://510kreport.com/company/dornier-medtech-america)
- KARL STORZ Endoscopy-America, Inc.: 1 (https://510kreport.com/company/karl-storz-endoscopy-america)

## Its most-cited devices
- K033222: Olympus Sterilization Trays (2004), cited by 8
- K141225: Esg-400, Footswitch Double Pedal, Footswitch Single Pedal, P-Cord (2014), cited by 6
- K100275: Working Element, Resection Button Electrode for Plasma Vaporizaton, HF-Resection Electrode Loops and Bands (2010), cited by 4
- K150633: ULTRA Telescopes (2015), cited by 3
- K102781: Resection Button Electrode for Plasma Vaporization, HF-Resection Electrode Rollers and Needles, Loops and Bands (2011), cited by 2
- K050502: Single Use Balloon Dilator Maxpasstm (2005), cited by 2

## Recent decisions
- K260649: OES ELITE Cystoscope and Accessories; Obturator, 17 Fr. (WA2C17BO); Obturator, 19.8 Fr. (WA2C19BO); Obturator, 21 Fr. (WA2C21BO); Obturator, 21 Fr., for sheath with ramp (WA2C21RO); Obturator, 21 Fr., long (WA2C21LO); Obturator, 21 Fr., for straight sheath (WA2C21SO); Obturator, 22.5 Fr. (WA2C22BO); Obturator, 25 Fr. (WA2C25BO); Obturator, optical, 19.8 Fr. (WA2C19BV); Obturator, optical, 21 Fr. (WA2C21BV); Obturator, optical, 21 Fr., for straight sheath (WA2C21SV); Obturator, optical, (May 21, 2026)
- K252043: Bipolar applicator CelonProBreath (WB990310); Bipolar applicator CelonProSleep plus (WB990311); Bipolar applicator CelonProBreath (WB990210); Bipolar applicator CelonProSleep plus (WB990211) (Sep 23, 2025)
- K231777: Electrosurgical Generator ESG-410 and Accessories (WA91327U, WA91327W), Accessories: Foot switches (WA91311W, WA91321W) (Aug 18, 2023)
- K221522: HF-cables (resusable) (Jan 19, 2023)
- K223183: Light-Guide Cables (Jan 13, 2023)
- K213207: Sheath, Stopcock Accessory (Dec 22, 2021)
- K203492: Instrument tray, for semi-rigid ureteroscope (Sep 15, 2021)
- K210651: Resection Electrodes with HF cable (Aug 3, 2021)

Source page: https://510kreport.com/company/olympus-winter-ibe