Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

43 results for "Olympus Winter & Ibe GmbH"
1–24 of 43
Search insights Median review: 94d Cleared: 100% Top manufacturer: Olympus Winter & Ibe GmbH Lead specialty: Gastroenterology & Urology
Cleared May 21, 2026
OES ELITE Cystoscope and Accessories
K260649 · FAJ
Olympus Winter & Ibe GmbH
Gastroenterology & Urology · 83d
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