Olympus Winter & Ibe GmbH
TELTOW Brandenburg, DE
OLYMPUS WINTER & IBE GMBH appears in FDA device records in TELTOW Brandenburg, DE. FDA records list 43 510(k) clearances between and , no PMA records and 2 registered establishments. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 43 510(k) clearances for Olympus Winter & Ibe GmbH between 1997 and 2026. The busiest year on record is 2016, with 5. The most recent is 2026, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1997 | 1 |
| 1998 | 1 |
| 1999 | 1 |
| 2002 | 1 |
| 2004 | 2 |
| 2005 | 1 |
| 2009 | 1 |
| 2010 | 1 |
| 2011 | 2 |
| 2012 | 2 |
| 2013 | 1 |
| 2014 | 4 |
| 2015 | 3 |
| 2016 | 5 |
| 2017 | 2 |
| 2018 | 3 |
| 2019 | 1 |
| 2020 | 1 |
| 2021 | 5 |
| 2023 | 3 |
| 2025 | 1 |
| 2026 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| 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 | |
| K252043 | Bipolar applicator CelonProBreath (WB990310); Bipolar applicator CelonProSleep plus (WB990311); Bipolar applicator CelonProBreath (WB990210); Bipolar applicator CelonProSleep plus (WB990211) | GEI | Substantially Equivalent | |
| K231777 | Electrosurgical Generator ESG-410 and Accessories (WA91327U, WA91327W), Accessories: Foot switches (WA91311W, WA91321W) | GEI | Substantially Equivalent | |
| K221522 | HF-cables (resusable) | GEI | Substantially Equivalent | |
| K223183 | Light-Guide Cables | HBI | Substantially Equivalent | |
| K213207 | Sheath, Stopcock Accessory | HIH | Substantially Equivalent | |
| K203492 | Instrument tray, for semi-rigid ureteroscope | KCT | Substantially Equivalent | |
| K210651 | Resection Electrodes with HF cable | FAS | Substantially Equivalent | |
| K203682 | Electrosurgical Generator ESG-400, Foot Switches, POWERSEAL Curved Jaw Sealer and Divider, Double Action | GEI | Substantially Equivalent | |
| K203277 | Electrosurgical Generator ESG-410, Foot Switches, PK Cutting Forceps | GEI | Substantially Equivalent | |
| K200369 | OES Elite Ureteroscopes and Accessories | FGB | Substantially Equivalent | |
| K190744 | ENDOEYE HD II (WA50040A, WA50042A, WA50050A, WA50052A) | HET | Substantially Equivalent | |
| K182587 | Device Electrosurgical Generator ESG-150 | GEI | Substantially Equivalent | |
| K180200 | ESG-300, APU-300, Pressure Reducer, MAPC Probes | GEI | Substantially Equivalent | |
| K171692 | Instrument basket, for EndoEYE | KCT | Substantially Equivalent | |
| K172535 | Bipolar applicator CELON ProCurve V | GEI | Substantially Equivalent | |
| K171965 | Resection Electrodes with HF cable | FAS | Substantially Equivalent | |
| K161600 | Resection Electrodes | JOS | Substantially Equivalent | |
| K160053 | Monopolar single-use HF cable | GEI | Substantially Equivalent | |
| K160639 | Electrosurgical Generator ESG-200 | GEI | Substantially Equivalent | |
| K160249 | ULTRA Telescopes | HRX | Substantially Equivalent | |
| K153009 | ULTRA Telescopes | EOB | Substantially Equivalent | |
| K151191 | OES ELITE Telescopes, Protective Tube | FBP | Substantially Equivalent | |
| K152092 | Resection Electrodes | FAS | Substantially Equivalent | |
| K150633 | ULTRA Telescopes | GCJ | Substantially Equivalent | |
| K140624 | HICURA HAND INSTRUMENTS | GEI | Substantially Equivalent | |
| K142525 | PK Lap Loop | HIN | Substantially Equivalent | |
| K141225 | ESG-400, FOOTSWITCH DOUBLE PEDAL, FOOTSWITCH SINGLE PEDAL, P-CORD | GEI | Substantially Equivalent | |
| K133311 | ENDOLED | NTN | Substantially Equivalent | |
| K130819 | CLL- V1 LIGHT SOURCE | NTN | Substantially Equivalent | |
| K120418 | ELECTROSUGRICAL RESECTION AND VAPORIZATION ELECTRODE SERIES | FAS | Substantially Equivalent | |
| K110748 | OLYMPUS INSTRUMENT TRAY | KCT | Substantially Equivalent | |
| K103032 | ESG-400 MODEL WB95051N, FOOTSWITCH DOUBLE PEDAL MODEL WB50402W, FOOTSWITCH SINGLE PEDAL MODEL WB50403W, P-CORD MODEL MAJ | GEI | Substantially Equivalent | |
| K102781 | RESECTION BUTTON ELECTRODE FOR PLASMA VAPORIZATION, HF-RESECTION ELECTRODE ROLLERS AND NEEDLES, LOOPS AND BANDS | FAS | Substantially Equivalent | |
| K100275 | WORKING ELEMENT, RESECTION BUTTON ELECTRODE FOR PLASMA VAPORIZATON, HF-RESECTION ELECTRODE LOOPS AND BANDS | FAS | Substantially Equivalent | |
| K090980 | HD ENDOEYE, MODELS WA50011A, WA50013A, WA50013L, WA50013T, WA50015L | NWB | Substantially Equivalent | |
| K050502 | SINGLE USE BALLOON DILATOR MAXPASSTM | FGE | Substantially Equivalent | |
| K033222 | OLYMPUS STERILIZATION TRAYS | KCT | Substantially Equivalent | |
| K033651 | OLYMPUS VIDEO URETEROSCOPE, NTSC | FGB | Substantially Equivalent | |
| K020507 | OLYMPUS NEUROSCOPE, MODELS S-1349/1, S-1349/2, S-1349/3 AND S-1349/4 | GWG | Substantially Equivalent | |
| K992141 | OLYMPUS WORKING ELEMENT FOR PROBES | FDC | Substantially Equivalent | |
| K983811 | UNIPOLAR OPTICAL BIOPSY FORCEPS | KGE | Substantially Equivalent | |
| K973232 | OLYMPUS SUBFASCIAL ENDOSCOPIC PERFORATING VEIN SURGERY (SEPS) SYSTEM, ITS ASSOCIATED ACCESSORIES AND ANCILLARY EQUIPMENT | GCJ | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 9610773 | 3002807798 | OLYMPUS WINTER & IBE GMBH | KUEHNSTRASSE 61, HAMBURG 22045 DE | 2026 | and 82 more, listed in full below |
| 3003724334 | 3003724334 | Olympus Winter & Ibe GmbH | Berlin facility, TELTOW Brandenburg 14513 DE | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- FFYAdaptor, Bulbs, Miscellaneous, For Endoscope
- FYDApparatus, Exhaust, Surgical
- HRXArthroscope
- EQJBur, Ear, Nose And Throat
- GEACannula, Surgical, General & Plastic Surgery
- JOLCatheter And Tip, Suction
- FZOChisel, Surgical, Manual
- HFICoagulator, Culdoscopic (And Accessories)
- HFGCoagulator, Laparoscopic, Unipolar (And Accessories)
- HINCoagulator-Cutter, Endoscopic, Bipolar (And Accessories)
- JYGCurette, Ear
- FAJCystoscope And Accessories, Flexible/Rigid
- DXJDisplay, Cathode-Ray Tube, Medical
- JOSElectrode, Electrosurgical
- FASElectrode, Electrosurgical, Active, Urological
- GEIElectrosurgical, Cutting & Coagulation & Accessories
- KADElevator, Ent
- GCPEndoscope, Ac-Powered And Accessories
- GWGEndoscope, Neurological
- GCMEndoscope, Rigid
- FEDEndoscopic Access Overtube, Gastroenterology-Urology
- FETEndoscopic Video Imaging System/Component, Gastroenterology-Urology
- HTDForceps
- KAEForceps, Ent
- GENForceps, General & Plastic Surgery
- GWXFork, Tuning
- JYJGauge, Measuring
- JYLHook, Microsurgical Ear
- HIHHysteroscope (And Accessories)
- HBIIlluminator, Fiberoptic, Surgical Field
- JYMInserter, Myringotomy Tube
- HCFInstrument, Ligature Passing And Knot Tying
- HIGInsufflator, Hysteroscopic
- FGAKit, Nephroscope
- JYOKnife, Ear
- GCJLaparoscope, General & Plastic Surgery
- HETLaparoscope, Gynecologic (And Accessories)
- CCWLaryngoscope, Rigid
- EQLLaryngostroboscope
- EBALight, Surgical Headlight
- HXLMallet
- EWYMediastinoscope, Surgical
- HKFMirror, Headband, Ophthalmic
- EOBNasopharyngoscope (Flexible Or Rigid)
- JYSPerforator, Ear-Lobe
- FEQPump, Air, Non-Manual, For Endoscope
- HTRRasp
- FJLResectoscope
- FDCResectoscope, Working Element
- EQHSource, Carrier, Fiberoptic Light
- GAFSpatula, Surgical, General & Plastic Surgery
- EPYSpeculum, Ent
- FGEStents, Drains And Dilators For The Biliary Ducts
- FBPTelescope, Rigid, Endoscopic
- FSMTray, Surgical, Instrument
- FCZTube, Smoke Removal, Endoscopic
- GAZTubing, Noninvasive
- FGBUreteroscope And Accessories, Flexible/Rigid
- FGCUrethroscope
- EZOUrethrotome
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain