ClearanceBrief
Company ยท DE

Olympus Winter & Ibe GmbH

FDA 510(k) clearances and medical device recalls filed under this name, 1997 to 2026. Name variants (Inc, Corp, punctuation) are merged.

43510(k) clearances (1 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)

Product codes

CodeDeviceRecords
GEIElectrosurgical, Cutting & Coagulation & Accessories13
FASElectrode, Electrosurgical, Active, Urological6
KCTSterilization Wrap Containers, Trays, Cassettes & Other Accessories4
FGBUreteroscope And Accessories, Flexible/Rigid2
GCJLaparoscope, General & Plastic Surgery2
NTNLed Light Source2
EOBNasopharyngoscope (Flexible Or Rigid)1
FAJCystoscope And Accessories, Flexible/Rigid1
FBPTelescope, Rigid, Endoscopic1
FDCResectoscope, Working Element1
FGEStents, Drains And Dilators For The Biliary Ducts1
GWGEndoscope, Neurological1
HBIIlluminator, Fiberoptic, Surgical Field1
HETLaparoscope, Gynecologic (And Accessories)1
HIHHysteroscope (And Accessories)1
HINCoagulator-Cutter, Endoscopic, Bipolar (And Accessories)1
HRXArthroscope1
JOSElectrode, Electrosurgical1
KGEForceps, Biopsy, Electric1
NWBEndoscope, Accessories, Narrow Band Spectrum1

Latest 510(k) clearances

Decided510(k)Device and applicantCode
May 21, 2026K260649OES ELITE Cystoscope and Accessories; Obturator, 17 Fr. (WA2C17BO); Obturator, 19.8 Fr. (WA2C19BO); Obturator, 21 Fr. (W
Olympus Winter & Ibe GmbH, DE
FAJ
Sep 23, 2025K252043Bipolar applicator CelonProBreath (WB990310); Bipolar applicator CelonProSleep plus (WB990311); Bipolar applicator Celon
Olympus Winter & Ibe GmbH, DE
GEI
Aug 18, 2023K231777Electrosurgical Generator ESG-410 and Accessories (WA91327U, WA91327W), Accessories: Foot switches (WA91311W, WA91321W)
Olympus Winter & Ibe GmbH, DE
GEI
Jan 19, 2023K221522HF-cables (resusable)
Olympus Winter & Ibe GmbH, DE
GEI
Jan 13, 2023K223183Light-Guide Cables
Olympus Winter & Ibe GmbH, DE
HBI
Dec 22, 2021K213207Sheath, Stopcock Accessory
Olympus Winter & Ibe GmbH, DE
HIH
Sep 15, 2021K203492Instrument tray, for semi-rigid ureteroscope
Olympus Winter & Ibe GmbH, DE
KCT
Aug 3, 2021K210651Resection Electrodes with HF cable
Olympus Winter & Ibe GmbH, DE
FAS
May 17, 2021K203682Electrosurgical Generator ESG-400, Foot Switches, POWERSEAL Curved Jaw Sealer and Divider, Double Action
Olympus Winter & Ibe GmbH, DE
GEI
Apr 28, 2021K203277Electrosurgical Generator ESG-410, Foot Switches, PK Cutting Forceps
Olympus Winter & Ibe GmbH, DE
GEI
Aug 28, 2020K200369OES Elite Ureteroscopes and Accessories
Olympus Winter & Ibe GmbH, DE
FGB
Aug 29, 2019K190744ENDOEYE HD II (WA50040A, WA50042A, WA50050A, WA50052A)
Olympus Winter & Ibe GmbH, DE
HET
Nov 29, 2018K182587Device Electrosurgical Generator ESG-150
Olympus Winter & Ibe GmbH, DE
GEI
Apr 26, 2018K180200ESG-300, APU-300, Pressure Reducer, MAPC Probes
Olympus Winter & Ibe GmbH, DE
GEI
Apr 2, 2018K171692Instrument basket, for EndoEYE
Olympus Winter & Ibe GmbH, DE
KCT
Nov 16, 2017K172535Bipolar applicator CELON ProCurve V
Olympus Winter & Ibe GmbH, DE
GEI
Sep 28, 2017K171965Resection Electrodes with HF cable
Olympus Winter & Ibe GmbH, DE
FAS
Sep 6, 2016K161600Resection Electrodes
Olympus Winter & Ibe GmbH, DE
JOS
May 6, 2016K160053Monopolar single-use HF cable
Olympus Winter & Ibe GmbH, DE
GEI
May 4, 2016K160639Electrosurgical Generator ESG-200
Olympus Winter & Ibe GmbH, DE
GEI
Apr 21, 2016K160249ULTRA Telescopes
Olympus Winter & Ibe GmbH, DE
HRX
Apr 5, 2016K153009ULTRA Telescopes
Olympus Winter & Ibe GmbH, DE
EOB
Nov 24, 2015K151191OES ELITE Telescopes, Protective Tube
Olympus Winter & Ibe GmbH, DE
FBP
Oct 26, 2015K152092Resection Electrodes
Olympus Winter & Ibe GmbH, DE
FAS
Apr 29, 2015K150633ULTRA Telescopes
Olympus Winter & Ibe GmbH, DE
GCJ
Dec 10, 2014K140624HICURA HAND INSTRUMENTS
Olympus Winter & Ibe GmbH
GEI
Nov 21, 2014K142525PK Lap Loop
Olympus Winter & Ibe GmbH, DE
HIN
Aug 12, 2014K141225ESG-400, FOOTSWITCH DOUBLE PEDAL, FOOTSWITCH SINGLE PEDAL, P-CORD
Olympus Winter & Ibe GmbH
GEI
Jul 30, 2014K133311ENDOLED
Olympus Winter & Ibe GmbH
NTN
Jun 19, 2013K130819CLL- V1 LIGHT SOURCE
Olympus Winter & Ibe GmbH
NTN
Jun 20, 2012K120418ELECTROSUGRICAL RESECTION AND VAPORIZATION ELECTRODE SERIES
Olympus Winter & Ibe GmbH
FAS
Feb 15, 2012K110748OLYMPUS INSTRUMENT TRAY
Olympus Winter & Ibe GmbH
KCT
Jan 14, 2011K103032ESG-400 MODEL WB95051N, FOOTSWITCH DOUBLE PEDAL MODEL WB50402W, FOOTSWITCH SINGLE PEDAL MODEL WB50403W, P-CORD MODEL MAJ
Olympus Winter & Ibe GmbH
GEI
Jan 11, 2011K102781RESECTION BUTTON ELECTRODE FOR PLASMA VAPORIZATION, HF-RESECTION ELECTRODE ROLLERS AND NEEDLES, LOOPS AND BANDS
Olympus Winter & Ibe GmbH
FAS
Jul 1, 2010K100275WORKING ELEMENT, RESECTION BUTTON ELECTRODE FOR PLASMA VAPORIZATON, HF-RESECTION ELECTRODE LOOPS AND BANDS
Olympus Winter & Ibe GmbH
FAS
Jun 29, 2009K090980HD ENDOEYE, MODELS WA50011A, WA50013A, WA50013L, WA50013T, WA50015L
Olympus Winter & Ibe GmbH
NWB
Jul 8, 2005K050502SINGLE USE BALLOON DILATOR MAXPASSTM
Olympus Winter & Ibe GmbH
FGE
Aug 2, 2004K033222OLYMPUS STERILIZATION TRAYS
Olympus Winter & Ibe GmbH
KCT
Jan 30, 2004K033651OLYMPUS VIDEO URETEROSCOPE, NTSC
Olympus Winter & Ibe GmbH
FGB
Oct 8, 2002K020507OLYMPUS NEUROSCOPE, MODELS S-1349/1, S-1349/2, S-1349/3 AND S-1349/4
Olympus Winter & Ibe GmbH
GWG
Sep 29, 1999K992141OLYMPUS WORKING ELEMENT FOR PROBES
Olympus Winter & Ibe GmbH
FDC
Dec 24, 1998K983811UNIPOLAR OPTICAL BIOPSY FORCEPS
Olympus Winter & Ibe GmbH
KGE
Nov 21, 1997K973232OLYMPUS SUBFASCIAL ENDOSCOPIC PERFORATING VEIN SURGERY (SEPS) SYSTEM, ITS ASSOCIATED ACCESSORIES AND ANCILLARY EQUIPMENT
Olympus Winter & Ibe GmbH, DE
GCJ

Latest recalls

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