Medical Device Manufacturer · US , Melville , NY

Olympus Winter & Ibe GmbH

42 submissions · 42 cleared · Since 1997
42
Total
42
Cleared
0
Denied

Olympus Winter & Ibe GmbH — FDA 510(k) Submissions

Olympus Winter & Ibe GmbH has submitted 42 FDA 510(k) premarket notifications since 1997, of which 42 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Electrosurgical, Cutting & Coagulation & Accessories, Electrode, Electrosurgical, Active, Urological, Sterilization Wrap Containers, Trays, Cassettes & Other Accessories, Led Light Source, Laparoscope, General & Plastic Surgery . Use the specialty filter in the sidebar to narrow results.

42 devices
1–25 of 42
Bipolar applicator CelonProBreath (WB990310); Bipolar applicator CelonProSleep plus (WB990311); Bipolar applicator CelonProBreath (WB990210); Bipolar applicator CelonProSleep plus (WB990211)
K252043 · GEI Electrosurgical, Cutting... · Ear, Nose, Throat
Sep 2025 85d
Electrosurgical Generator ESG-410 and Accessories (WA91327U, WA91327W), Accessories: Foot switches (WA91311W, WA91321W)
K231777 · GEI Electrosurgical, Cutting... · General & Plastic Surgery
Aug 2023 63d
HF-cables (resusable)
K221522 · GEI Electrosurgical, Cutting... · Gastroenterology & Urology
Jan 2023 238d
Light-Guide Cables
K223183 · HBI Illuminator, Fiberoptic,... · General & Plastic Surgery
Jan 2023 93d
Sheath, Stopcock Accessory
K213207 · HIH Hysteroscope (and... · Obstetrics & Gynecology
Dec 2021 84d
Instrument tray, for semi-rigid ureteroscope
K203492 · KCT Sterilization Wrap... · General Hospital
Sep 2021 300d
Resection Electrodes with HF cable
K210651 · FAS Electrode,... · Obstetrics & Gynecology
Aug 2021 152d
Electrosurgical Generator ESG-400, Foot Switches, POWERSEAL Curved Jaw Sealer and Divider, Double Action
K203682 · GEI Electrosurgical, Cutting... · General & Plastic Surgery
May 2021 151d
Electrosurgical Generator ESG-410, Foot Switches, PK Cutting Forceps
K203277 · GEI Electrosurgical, Cutting... · General & Plastic Surgery
Apr 2021 173d
OES Elite Ureteroscopes and Accessories
K200369 · FGB Ureteroscope And... · Gastroenterology & Urology
Aug 2020 196d
ENDOEYE HD II (WA50040A, WA50042A, WA50050A, WA50052A)
K190744 · HET Laparoscope, Gynecologic... · Obstetrics & Gynecology
Aug 2019 160d
Device Electrosurgical Generator ESG-150
K182587 · GEI Electrosurgical, Cutting... · General & Plastic Surgery
Nov 2018 70d
ESG-300, APU-300, Pressure Reducer, MAPC Probes
K180200 · GEI Electrosurgical, Cutting... · General & Plastic Surgery
Apr 2018 92d
Instrument basket, for EndoEYE
K171692 · KCT Sterilization Wrap... · General Hospital
Apr 2018 299d
Bipolar applicator CELON ProCurve V
K172535 · GEI Electrosurgical, Cutting... · General & Plastic Surgery
Nov 2017 86d
Resection Electrodes with HF cable
K171965 · FAS Electrode,... · Gastroenterology & Urology
Sep 2017 90d
Resection Electrodes
K161600 · JOS Electrode, Electrosurgical · General & Plastic Surgery
Sep 2016 89d
Monopolar single-use HF cable
K160053 · GEI Electrosurgical, Cutting... · General & Plastic Surgery
May 2016 116d
Electrosurgical Generator ESG-200
K160639 · GEI Electrosurgical, Cutting... · General & Plastic Surgery
May 2016 58d
ULTRA Telescopes
K160249 · HRX Arthroscope · Orthopedic
Apr 2016 80d
ULTRA Telescopes
K153009 · EOB Nasopharyngoscope... · Ear, Nose, Throat
Apr 2016 174d
OES ELITE Telescopes, Protective Tube
K151191 · FBP Telescope, Rigid, Endoscopic · Gastroenterology & Urology
Nov 2015 204d
Resection Electrodes
K152092 · FAS Electrode,... · Gastroenterology & Urology
Oct 2015 90d
ULTRA Telescopes
K150633 · GCJ Laparoscope, General &... · General & Plastic Surgery
Apr 2015 49d
HICURA HAND INSTRUMENTS
K140624 · GEI Electrosurgical, Cutting... · General & Plastic Surgery
Dec 2014 274d
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