Search FDA 510(k) Devices

Cleared Sep 23, 2025

Bipolar applicator CelonProBreath (WB990310)

K252043 · GEI

Olympus Winter & Ibe GmbH

Ear, Nose, Throat · 85d

Cleared Aug 18, 2023

Electrosurgical Generator ESG-410 and Accessories (WA91327U, WA91327W),...

K231777 · GEI

Olympus Winter & Ibe GmbH

General & Plastic Surgery · 63d

Cleared Jan 19, 2023

HF-cables (resusable)

K221522 · GEI

Olympus Winter & Ibe GmbH

Gastroenterology & Urology · 238d

Cleared Jan 13, 2023

Light-Guide Cables

K223183 · HBI

Olympus Winter & Ibe GmbH

General & Plastic Surgery · 93d

Cleared Dec 22, 2021

Sheath, Stopcock Accessory

K213207 · HIH

Olympus Winter & Ibe GmbH

Obstetrics & Gynecology · 84d

Cleared Sep 15, 2021

Instrument tray, for semi-rigid ureteroscope

K203492 · KCT

Olympus Winter & Ibe GmbH

General Hospital · 300d

Cleared Aug 03, 2021

Resection Electrodes with HF cable

K210651 · FAS

Olympus Winter & Ibe GmbH

Obstetrics & Gynecology · 152d

Cleared May 17, 2021

Electrosurgical Generator ESG-400, Foot Switches, POWERSEAL Curved Jaw Sealer...

K203682 · GEI

Olympus Winter & Ibe GmbH

General & Plastic Surgery · 151d

Cleared Apr 28, 2021

Electrosurgical Generator ESG-410, Foot Switches, PK Cutting Forceps

K203277 · GEI

Olympus Winter & Ibe GmbH

General & Plastic Surgery · 173d

Cleared Aug 28, 2020

OES Elite Ureteroscopes and Accessories

K200369 · FGB

Olympus Winter & Ibe GmbH

Gastroenterology & Urology · 196d

Cleared Aug 29, 2019

ENDOEYE HD II (WA50040A, WA50042A, WA50050A, WA50052A)

K190744 · HET

Olympus Winter & Ibe GmbH

Obstetrics & Gynecology · 160d

Cleared Nov 29, 2018

Device Electrosurgical Generator ESG-150

K182587 · GEI

Olympus Winter & Ibe GmbH

General & Plastic Surgery · 70d

Cleared Apr 26, 2018

ESG-300, APU-300, Pressure Reducer, MAPC Probes

K180200 · GEI

Olympus Winter & Ibe GmbH

General & Plastic Surgery · 92d

Cleared Apr 02, 2018

Instrument basket, for EndoEYE

K171692 · KCT

Olympus Winter & Ibe GmbH

General Hospital · 299d

Cleared Nov 16, 2017

Bipolar applicator CELON ProCurve V

K172535 · GEI

Olympus Winter & Ibe GmbH

General & Plastic Surgery · 86d

Cleared Sep 28, 2017

Resection Electrodes with HF cable

K171965 · FAS

Olympus Winter & Ibe GmbH

Gastroenterology & Urology · 90d

Cleared Sep 06, 2016

Resection Electrodes

K161600 · JOS

Olympus Winter & Ibe GmbH

General & Plastic Surgery · 89d

Cleared May 06, 2016

Monopolar single-use HF cable

K160053 · GEI

Olympus Winter & Ibe GmbH

General & Plastic Surgery · 116d

Cleared May 04, 2016

Electrosurgical Generator ESG-200

K160639 · GEI

Olympus Winter & Ibe GmbH

General & Plastic Surgery · 58d

Cleared Apr 21, 2016

ULTRA Telescopes

K160249 · HRX

Olympus Winter & Ibe GmbH

Orthopedic · 80d

Cleared Apr 05, 2016

ULTRA Telescopes

K153009 · EOB

Olympus Winter & Ibe GmbH

Ear, Nose, Throat · 174d

Cleared Nov 24, 2015

OES ELITE Telescopes, Protective Tube

K151191 · FBP

Olympus Winter & Ibe GmbH

Gastroenterology & Urology · 204d

Cleared Oct 26, 2015

Resection Electrodes

K152092 · FAS

Olympus Winter & Ibe GmbH

Gastroenterology & Urology · 90d

Cleared Apr 29, 2015

ULTRA Telescopes

K150633 · GCJ

Olympus Winter & Ibe GmbH

General & Plastic Surgery · 49d