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Olympus Winter & Ibe GmbH

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
42
Inspections
6
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K252043Bipolar applicator CelonProBreath (WB990310); Bipolar applicator CelonProSleep plus (WB990311); BipoSeptember 23, 2025
K231777Electrosurgical Generator ESG-410 and Accessories (WA91327U, WA91327W), Accessories: Foot switches (August 18, 2023
K221522HF-cables (resusable)January 19, 2023
K223183Light-Guide CablesJanuary 13, 2023
K213207Sheath, Stopcock AccessoryDecember 22, 2021
K203492Instrument tray, for semi-rigid ureteroscopeSeptember 15, 2021
K210651Resection Electrodes with HF cableAugust 3, 2021
K203682Electrosurgical Generator ESG-400, Foot Switches, POWERSEAL Curved Jaw Sealer and Divider, Double AcMay 17, 2021
K203277Electrosurgical Generator ESG-410, Foot Switches, PK Cutting ForcepsApril 28, 2021
K200369OES Elite Ureteroscopes and AccessoriesAugust 28, 2020
K190744ENDOEYE HD II (WA50040A, WA50042A, WA50050A, WA50052A)August 29, 2019
K182587Device Electrosurgical Generator ESG-150November 29, 2018
K180200ESG-300, APU-300, Pressure Reducer, MAPC ProbesApril 26, 2018
K171692Instrument basket, for EndoEYEApril 2, 2018
K172535Bipolar applicator CELON ProCurve VNovember 16, 2017
K171965Resection Electrodes with HF cableSeptember 28, 2017
K161600Resection ElectrodesSeptember 6, 2016
K160053Monopolar single-use HF cableMay 6, 2016
K160639Electrosurgical Generator ESG-200May 4, 2016
K160249ULTRA TelescopesApril 21, 2016