Data / Medical devices / Germany / Olympus Winter & Ibe GMBH
Olympus Winter & Ibe GMBH: FDA-registered device maker in Hamburg, Germany, 90 510(k) clearances
Olympus Winter & Ibe GMBH is registered with the FDA (registration 9610773) in Hamburg, Germany. It lists 92 device types. The FDA files 90 510(k) clearances under its listings, the newest dated May 21, 2026. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 9610773
- FEI number
- 3002807798
- Address
- Kuehnstrasse 61, Hamburg, Germany, 22045
- Owner or operator
- OLYMPUS CORPORATION (9067818)
- Roles
- Complaint file establishment, Contract manufacturer, Exporter to the US, Foreign private label distributor, Manufacturer, Specification developer
- First device listed
- January 20, 1995
- Registered through
- 2027
- Brand names listed
- A5961, A5976, A05951A, A05961A,WA05970A, WA05971A , WA05972A, WA05973A, WA05974A, WA05990A, WA05994A, WA05995A, AD-CO2- OUS, ADA-CO2-OUS, Adenoid forceps, Adenotome, Artery forceps, Arthroscopes, CLV-S20 light source, Articulated arm and accessories, Austin Tympanoplasty 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 |
|---|---|---|---|---|---|---|
| May 21, 2026 | 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, | FAJ | Substantially Equivalent | Olympus Winter & Ibe GmbH | accessdata.fda.gov |
| September 23, 2025 | K252043 | Bipolar applicator CelonProBreath (WB990310); Bipolar applicator CelonProSleep plus (WB990311); Bipolar applicator CelonProBreath (WB990210); Bipolar applicator CelonProSleep plus (WB990211) | GEI | Substantially Equivalent | Olympus Winter & Ibe GmbH | accessdata.fda.gov |
| August 18, 2023 | K231777 | Electrosurgical Generator ESG-410 and Accessories (WA91327U, WA91327W), Accessories: Foot switches (WA91311W, WA91321W) | GEI | Substantially Equivalent | Olympus Winter & Ibe GmbH | accessdata.fda.gov |
| January 19, 2023 | K221522 | HF-cables (resusable) | GEI | Substantially Equivalent | Olympus Winter & Ibe GmbH | accessdata.fda.gov |
| January 13, 2023 | K223183 | Light-Guide Cables | HBI | Substantially Equivalent | Olympus Winter & Ibe GmbH | accessdata.fda.gov |
| December 22, 2021 | K213207 | Sheath, Stopcock Accessory | HIH | Substantially Equivalent | Olympus Winter & Ibe GmbH | accessdata.fda.gov |
| September 15, 2021 | K203492 | Instrument tray, for semi-rigid ureteroscope | KCT | Substantially Equivalent | Olympus Winter & Ibe GmbH | accessdata.fda.gov |
| August 3, 2021 | K210651 | Resection Electrodes with HF cable | FAS | Substantially Equivalent | Olympus Winter & Ibe GmbH | accessdata.fda.gov |
| July 30, 2021 | K200770 | Mini PCNL-System | FED | Substantially Equivalent | Trokamed GmbH | accessdata.fda.gov |
| June 25, 2021 | K210138 | iTind System | QKA | Substantially Equivalent | Medi-Tate , Ltd. | accessdata.fda.gov |
| May 17, 2021 | K203682 | Electrosurgical Generator ESG-400, Foot Switches, POWERSEAL Curved Jaw Sealer and Divider, Double Action | GEI | Substantially Equivalent | Olympus Winter & Ibe GmbH | accessdata.fda.gov |
| April 28, 2021 | K203277 | Electrosurgical Generator ESG-410, Foot Switches, PK Cutting Forceps | GEI | Substantially Equivalent | Olympus Winter & Ibe GmbH | accessdata.fda.gov |
| August 28, 2020 | K200369 | OES Elite Ureteroscopes and Accessories | FGB | Substantially Equivalent | Olympus Winter & Ibe GmbH | accessdata.fda.gov |
| July 17, 2020 | K200542 | Visera Elite II Xenon Light Source, Telescope IR/Telescope Ultra, Visera Elite II Video System Center, HD 3CMOS Autoclavable Camera Head, HD 3CMOS Camera Head | OWN | Substantially Equivalent | Olympus Medical Systems Corp. | accessdata.fda.gov |
| April 3, 2020 | K193026 | Visera Elite II Video System Center, Visera Elite II Endoeye 3D | GCJ | Substantially Equivalent | Olympus Medical Systems Corp. | accessdata.fda.gov |
| February 25, 2020 | K192898 | PneumoLiner | PMU | Substantially Equivalent | Advanced Surgical Concepts | accessdata.fda.gov |
| August 29, 2019 | K190744 | ENDOEYE HD II (WA50040A, WA50042A, WA50050A, WA50052A) | HET | Substantially Equivalent | Olympus Winter & Ibe GmbH | accessdata.fda.gov |
| November 29, 2018 | K182587 | Device Electrosurgical Generator ESG-150 | GEI | Substantially Equivalent | Olympus Winter & Ibe GmbH | accessdata.fda.gov |
| April 26, 2018 | K180200 | ESG-300, APU-300, Pressure Reducer, MAPC Probes | GEI | Substantially Equivalent | Olympus Winter & Ibe GmbH | accessdata.fda.gov |
| April 2, 2018 | K171692 | Instrument basket, for EndoEYE | KCT | Substantially Equivalent | Olympus Winter & Ibe GmbH | accessdata.fda.gov |
| February 15, 2018 | K173877 | BOWA Neutral Electrodes | GEI | Substantially Equivalent | Bowa-Electronics GmbH & Co. KG | accessdata.fda.gov |
| September 28, 2017 | K171965 | Resection Electrodes with HF cable | FAS | Substantially Equivalent | Olympus Winter & Ibe GmbH | accessdata.fda.gov |
| September 6, 2016 | K161600 | Resection Electrodes | JOS | Substantially Equivalent | Olympus Winter & Ibe GmbH | accessdata.fda.gov |
| May 6, 2016 | K160053 | Monopolar single-use HF cable | GEI | Substantially Equivalent | Olympus Winter & Ibe GmbH | accessdata.fda.gov |
| May 4, 2016 | K160639 | Electrosurgical Generator ESG-200 | GEI | Substantially Equivalent | Olympus Winter & Ibe GmbH | accessdata.fda.gov |
| April 21, 2016 | K160249 | ULTRA Telescopes | HRX | Substantially Equivalent | Olympus Winter & Ibe GmbH | accessdata.fda.gov |
| April 5, 2016 | K153009 | ULTRA Telescopes | EOB | Substantially Equivalent | Olympus Winter & Ibe GmbH | accessdata.fda.gov |
| November 24, 2015 | K151191 | OES ELITE Telescopes, Protective Tube | FBP | Substantially Equivalent | Olympus Winter & Ibe GmbH | accessdata.fda.gov |
| October 26, 2015 | K152092 | Resection Electrodes | FAS | Substantially Equivalent | Olympus Winter & Ibe GmbH | accessdata.fda.gov |
| June 30, 2015 | K143474 | Artemis Hand Held Imaging System | OWN | Substantially Equivalent | Quest Medical Imaging | accessdata.fda.gov |
| April 29, 2015 | K150633 | ULTRA Telescopes | GCJ | Substantially Equivalent | Olympus Winter & Ibe GmbH | accessdata.fda.gov |
| February 20, 2015 | K150024 | Bissinger Monopolar Cables | GEI | Substantially Equivalent | Guenter Bissinger Medizintechnik GmbH | accessdata.fda.gov |
| January 27, 2015 | K142249 | SCHOELLY SINUSCOPE | EOB | Substantially Equivalent | Schoelly Fiberoptic GmbH | accessdata.fda.gov |
| December 10, 2014 | K140624 | HICURA HAND INSTRUMENTS | GEI | Substantially Equivalent | Olympus Winter & Ibe GmbH | accessdata.fda.gov |
| November 21, 2014 | K142525 | PK Lap Loop | HIN | Substantially Equivalent | Olympus Winter & Ibe GmbH | accessdata.fda.gov |
| July 30, 2014 | K133311 | ENDOLED | NTN | Substantially Equivalent | Olympus Winter & Ibe GmbH | accessdata.fda.gov |
| March 3, 2014 | K131402 | VISICLEAR SMOKE EVACUATION SYSTEM | FYD | Substantially Equivalent | Buffalo Filter Co., Inc. | accessdata.fda.gov |
| April 22, 2013 | K122167 | NEXXIS OR | DXJ | Substantially Equivalent | Barco N.V. | accessdata.fda.gov |
| April 4, 2013 | K123732 | HYSTEROSCOPY PUMP HM6 | HIG | Substantially Equivalent | W.O.M. World of Medicine AG | accessdata.fda.gov |
| June 20, 2012 | K120418 | ELECTROSUGRICAL RESECTION AND VAPORIZATION ELECTRODE SERIES | FAS | Substantially Equivalent | Olympus Winter & Ibe GmbH | accessdata.fda.gov |
| February 15, 2012 | K110748 | OLYMPUS INSTRUMENT TRAY | KCT | Substantially Equivalent | Olympus Winter & Ibe GmbH | accessdata.fda.gov |
| January 20, 2012 | K111202 | SURGICAL TISSUE MANAGEMENT SYSTEM | GEI | Substantially Equivalent | Olympus Medical Systems Corp. | accessdata.fda.gov |
| December 2, 2011 | K111751 | VERSAPOINT II BIPOLAR ELECTROSURGERY GENERATOR, VERSAPOINT II 44MM ANGLED LOOP ELECTRODE, VERSAPOINT II FOOTSWITCH, VERS | HIN | Substantially Equivalent | ETHICON, Inc. | accessdata.fda.gov |
| November 25, 2011 | K111342 | LIGHT GUIDE CABLE | HBI | Substantially Equivalent | Schott North America | accessdata.fda.gov |
| March 16, 2011 | K103375 | PLUMEPEN INTEGRATED SMOKE EVACUATION PENCIL | GEI | Substantially Equivalent | Medtek Devices, Inc. | accessdata.fda.gov |
| July 1, 2010 | K100275 | WORKING ELEMENT, RESECTION BUTTON ELECTRODE FOR PLASMA VAPORIZATON, HF-RESECTION ELECTRODE LOOPS AND BANDS | FAS | Substantially Equivalent | Olympus Winter & Ibe GmbH | accessdata.fda.gov |
| June 29, 2009 | K090980 | HD ENDOEYE, MODELS WA50011A, WA50013A, WA50013L, WA50013T, WA50015L | NWB | Substantially Equivalent | Olympus Winter & Ibe GmbH | accessdata.fda.gov |
| May 8, 2008 | K073207 | OLYMPUS ESG-100, MODEL WB991046; OLYMPUS AFU-100, MODEL WB950167 | GEI | Substantially Equivalent | Celon AG Medical Instruments | accessdata.fda.gov |
| September 14, 2007 | K070812 | DISPOSABLE LAPAROSCOPIC INSTRUMENT | GEI | Substantially Equivalent | Modern Medical Equipment Mfg., Ltd. | accessdata.fda.gov |
| August 2, 2004 | K033222 | OLYMPUS STERILIZATION TRAYS | KCT | Substantially Equivalent | Olympus Winter & Ibe GmbH | accessdata.fda.gov |
| March 9, 2004 | K040302 | VERSAPOINT RESECTOSCOPIC SYSTEM | HIH | Substantially Equivalent | Gynecare, A Div. of Ethicon, Inc. | accessdata.fda.gov |
| September 26, 2003 | K032838 | CELON ENT SYSTEM | GEI | Substantially Equivalent | Celon AG Medical Instruments | accessdata.fda.gov |
| April 10, 2003 | K022449 | HYSTEREOSCOPY PUMP HM4 | HIG | Substantially Equivalent | W.O.M. World of Medicine AG | accessdata.fda.gov |
| March 24, 2003 | K030194 | XUES-41 ENDOSCOPIC ELECTROSURGICAL UNIT | KNS | Substantially Equivalent | The Olympus Optical Co. | accessdata.fda.gov |
| June 8, 2000 | K000904 | PENADAPT 10 | FYD | Substantially Equivalent | Buffalo Filter Co., Inc. | accessdata.fda.gov |
| January 24, 2000 | K994418 | VERSAPOINT ELECTROSURGERY SYSTEM (SCUBA) | HIH | Substantially Equivalent | ETHICON, Inc. | accessdata.fda.gov |
| January 18, 2000 | K992901 | GYNECARE VERSAPOINT G-VAP ELECTRODE | HIH | Substantially Equivalent | Gynecare, Inc. | accessdata.fda.gov |
| September 29, 1999 | K992141 | OLYMPUS WORKING ELEMENT FOR PROBES | FDC | Substantially Equivalent | Olympus Winter & Ibe GmbH | accessdata.fda.gov |
| July 12, 1999 | K990237 | TROCAR SYSTEM ACCORDING TO HASSON | GCJ | Substantially Equivalent | Olympus America, Inc. | accessdata.fda.gov |
| March 1, 1999 | K982738 | VERSAPOINT ELECTROSURGERY SYSTEM (SCUBA) | HIH | Substantially Equivalent | Gynecare, Inc. | accessdata.fda.gov |
| February 24, 1999 | K984417 | BIPOLAR GRASPING FORCEPS BIQ+ | GEI | Substantially Equivalent | Olympus America, Inc. | accessdata.fda.gov |
| December 24, 1998 | K983811 | UNIPOLAR OPTICAL BIOPSY FORCEPS | KGE | Substantially Equivalent | Olympus Winter & Ibe GmbH | accessdata.fda.gov |
| March 6, 1997 | K954488 | ROLLER ELECTRODE | HIH | Substantially Equivalent | Olympus America, Inc. | accessdata.fda.gov |
| November 1, 1996 | K962482 | SCUBA SYSTEM | HIH | Substantially Equivalent | Gynecare, Inc. | accessdata.fda.gov |
| February 13, 1996 | K955623 | OLYMPUS BIPOLAR FORCEPS | GEI | Substantially Equivalent | Olympus America, Inc. | accessdata.fda.gov |
| September 15, 1995 | K944200 | HI-Q HAND INSTRUMENTS, OB/GYN USE | HET | Substantially Equivalent | Olympus America, Inc. | accessdata.fda.gov |
| August 24, 1995 | K951863 | ROLLER ELECTRODE | FAS | Substantially Equivalent | Olympus America, Inc. | accessdata.fda.gov |
| August 16, 1995 | K951855 | ULTRATHIN URETEROSCOPES | FGB | Substantially Equivalent | Olympus America, Inc. | accessdata.fda.gov |
| June 14, 1995 | K951354 | OLYMPUS ARTHROSCOPY SYSTEM | HRX | Substantially Equivalent | Olympus America, Inc. | accessdata.fda.gov |
| March 3, 1995 | K950076 | LAPAROSCOPE | GCJ | Substantially Equivalent | Olympus America, Inc. | accessdata.fda.gov |
| February 21, 1995 | K950055 | A4722 OLYMPUS OPTICAL OBTURATOR | HIH | Substantially Equivalent | Olympus America, Inc. | accessdata.fda.gov |
| February 1, 1995 | K950278 | MINI LAPAROSCOPY FOR GENERAL SURGERY | GCJ | Substantially Equivalent | Olympus America, Inc. | accessdata.fda.gov |
| January 11, 1995 | K944072 | OLYMPUS NASAL AND SINUS ENDOSCOPES | EOB | Substantially Equivalent | Olympus America, Inc. | accessdata.fda.gov |
| November 29, 1994 | K944201 | HI-Q HAND INSTRUMENTS- UROLOGY | GCJ | Substantially Equivalent | Olympus America, Inc. | accessdata.fda.gov |
| August 29, 1994 | K931763 | HF-RESECTION ELECTRODE, LOOP W/RUNNER ENDOS/ACCESS | FAS | Substantially Equivalent | Olympus Corp. | accessdata.fda.gov |
| June 8, 1994 | K931764 | HF RESECTION ELECTRODE, LOOP W/RUNNER HYSTER/ACCES | HIH | Substantially Equivalent | Olympus Corp. | accessdata.fda.gov |
| February 17, 1994 | K931994 | RESECTOSCOPE SHEATH | HIH | Substantially Equivalent | Olympus Corp. | accessdata.fda.gov |
| November 3, 1993 | K930041 | VICROSAFE 6 AND VICROSAFE 12 | FYD | Substantially Equivalent | Buffalo Filter Co., Inc. | accessdata.fda.gov |
| September 13, 1993 | K924732 | PORTA PLUMESAFE(TM) 601 SMOKE EVACUATION SYSTEM | FYD | Substantially Equivalent | Buffalo Filter Co., Inc. | accessdata.fda.gov |
| July 23, 1993 | K931995 | RESECTOSCOPE SHEATH | FJL | Substantially Equivalent | Olympus Corp. | accessdata.fda.gov |
| March 15, 1993 | K923982 | OLYMPUS OES LAPAROSCOPY SYSTEM | GCJ | Substantially Equivalent | Olympus Corp. | accessdata.fda.gov |
| January 13, 1992 | K904940 | OLYMPUS INFANT RESECTOSCOPE AND ACCESSORIES | FJL | Substantially Equivalent | Olympus Corp. | accessdata.fda.gov |
| January 7, 1992 | K904939 | FLEXIBLE AND RIGID URETEROTOME SYSTEM | EZO | Substantially Equivalent | Olympus Corp. | accessdata.fda.gov |
| October 24, 1991 | K912362 | OES THORACOSCOPE SYSTEM | EWY | Substantially Equivalent | Olympus Corp. | accessdata.fda.gov |
| October 1, 1990 | K903323 | RESECTOSCOPE LOOPS | KNS | Substantially Equivalent | Olympus Corp. | accessdata.fda.gov |
| March 16, 1990 | K897003 | OLYMPUS HYSTERORESECTOSCOPE | HIH | Substantially Equivalent | Olympus Corp. | accessdata.fda.gov |
| October 2, 1989 | K891451 | OLYMPUS HYF-P FLEXIBLE HYSTEROFIBERSCOPE | HIH | Substantially Equivalent | Olympus Corp. | accessdata.fda.gov |
| September 12, 1985 | K853486 | OLYMPUS RIGID PERCUTANEOUS NEPHROSCOPE | FGA | Substantially Equivalent | Olympus Corp. | accessdata.fda.gov |
| August 21, 1985 | K852888 | OLYMPUS RIGID URETERORENOSCOPE | FGB | Substantially Equivalent | Olympus Corp. | accessdata.fda.gov |
| April 2, 1979 | K790071 | ENDOSCOPE AND ACCESSORIES | GCP | Substantially Equivalent | Olympus Corp. | accessdata.fda.gov |
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Updated May 21, 2026. 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.