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Olympus Winter & Ibe GmbH

43 FDA 510(k) clearances · Manufacturer

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RecordFirmDate
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, (K260649)Olympus Winter & Ibe GmbH2026-05-21
Bipolar applicator CelonProBreath (WB990310); Bipolar applicator CelonProSleep plus (WB990311); Bipolar applicator CelonProBreath (WB990210); Bipolar applicator CelonProSleep plus (WB990211) (K252043)Olympus Winter & Ibe GmbH2025-09-23
Electrosurgical Generator ESG-410 and Accessories (WA91327U, WA91327W), Accessories: Foot switches (WA91311W, WA91321W) (K231777)Olympus Winter & Ibe GmbH2023-08-18
HF-cables (resusable) (K221522)Olympus Winter & Ibe GmbH2023-01-19
Light-Guide Cables (K223183)Olympus Winter & Ibe GmbH2023-01-13
Sheath, Stopcock Accessory (K213207)Olympus Winter & Ibe GmbH2021-12-22
Instrument tray, for semi-rigid ureteroscope (K203492)Olympus Winter & Ibe GmbH2021-09-15
Resection Electrodes with HF cable (K210651)Olympus Winter & Ibe GmbH2021-08-03
Electrosurgical Generator ESG-400, Foot Switches, POWERSEAL Curved Jaw Sealer and Divider, Double Action (K203682)Olympus Winter & Ibe GmbH2021-05-17
Electrosurgical Generator ESG-410, Foot Switches, PK Cutting Forceps (K203277)Olympus Winter & Ibe GmbH2021-04-28
OES Elite Ureteroscopes and Accessories (K200369)Olympus Winter & Ibe GmbH2020-08-28
ENDOEYE HD II (WA50040A, WA50042A, WA50050A, WA50052A) (K190744)Olympus Winter & Ibe GmbH2019-08-29
Device Electrosurgical Generator ESG-150 (K182587)Olympus Winter & Ibe GmbH2018-11-29
ESG-300, APU-300, Pressure Reducer, MAPC Probes (K180200)Olympus Winter & Ibe GmbH2018-04-26
Instrument basket, for EndoEYE (K171692)Olympus Winter & Ibe GmbH2018-04-02
Bipolar applicator CELON ProCurve V (K172535)Olympus Winter & Ibe GmbH2017-11-16
Resection Electrodes with HF cable (K171965)Olympus Winter & Ibe GmbH2017-09-28
Resection Electrodes (K161600)Olympus Winter & Ibe GmbH2016-09-06
Monopolar single-use HF cable (K160053)Olympus Winter & Ibe GmbH2016-05-06
Electrosurgical Generator ESG-200 (K160639)Olympus Winter & Ibe GmbH2016-05-04
ULTRA Telescopes (K160249)Olympus Winter & Ibe GmbH2016-04-21
ULTRA Telescopes (K153009)Olympus Winter & Ibe GmbH2016-04-05
OES ELITE Telescopes, Protective Tube (K151191)Olympus Winter & Ibe GmbH2015-11-24
Resection Electrodes (K152092)Olympus Winter & Ibe GmbH2015-10-26
ULTRA Telescopes (K150633)Olympus Winter & Ibe GmbH2015-04-29
HICURA HAND INSTRUMENTS (K140624)Olympus Winter & Ibe GmbH2014-12-10
PK Lap Loop (K142525)Olympus Winter & Ibe GmbH2014-11-21
ESG-400, FOOTSWITCH DOUBLE PEDAL, FOOTSWITCH SINGLE PEDAL, P-CORD (K141225)Olympus Winter & Ibe GmbH2014-08-12
ENDOLED (K133311)Olympus Winter & Ibe GmbH2014-07-30
CLL- V1 LIGHT SOURCE (K130819)Olympus Winter & Ibe GmbH2013-06-19
ELECTROSUGRICAL RESECTION AND VAPORIZATION ELECTRODE SERIES (K120418)Olympus Winter & Ibe GmbH2012-06-20
OLYMPUS INSTRUMENT TRAY (K110748)Olympus Winter & Ibe GmbH2012-02-15
ESG-400 MODEL WB95051N, FOOTSWITCH DOUBLE PEDAL MODEL WB50402W, FOOTSWITCH SINGLE PEDAL MODEL WB50403W, P-CORD MODEL MAJ (K103032)Olympus Winter & Ibe GmbH2011-01-14
RESECTION BUTTON ELECTRODE FOR PLASMA VAPORIZATION, HF-RESECTION ELECTRODE ROLLERS AND NEEDLES, LOOPS AND BANDS (K102781)Olympus Winter & Ibe GmbH2011-01-11
WORKING ELEMENT, RESECTION BUTTON ELECTRODE FOR PLASMA VAPORIZATON, HF-RESECTION ELECTRODE LOOPS AND BANDS (K100275)Olympus Winter & Ibe GmbH2010-07-01
HD ENDOEYE, MODELS WA50011A, WA50013A, WA50013L, WA50013T, WA50015L (K090980)Olympus Winter & Ibe GmbH2009-06-29
SINGLE USE BALLOON DILATOR MAXPASSTM (K050502)Olympus Winter & Ibe GmbH2005-07-08
OLYMPUS STERILIZATION TRAYS (K033222)Olympus Winter & Ibe GmbH2004-08-02
OLYMPUS VIDEO URETEROSCOPE, NTSC (K033651)Olympus Winter & Ibe GmbH2004-01-30
OLYMPUS NEUROSCOPE, MODELS S-1349/1, S-1349/2, S-1349/3 AND S-1349/4 (K020507)Olympus Winter & Ibe GmbH2002-10-08
OLYMPUS WORKING ELEMENT FOR PROBES (K992141)Olympus Winter & Ibe GmbH1999-09-29
UNIPOLAR OPTICAL BIOPSY FORCEPS (K983811)Olympus Winter & Ibe GmbH1998-12-24
OLYMPUS SUBFASCIAL ENDOSCOPIC PERFORATING VEIN SURGERY (SEPS) SYSTEM, ITS ASSOCIATED ACCESSORIES AND ANCILLARY EQUIPMENT (K973232)Olympus Winter & Ibe GmbH1997-11-21

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Every clearance here is in the API, with alerts when new ones post.