Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Olympus Winter & Ibe GmbH

FDA 510(k) & PMA Approved Devices — 21 products

Total Devices21
Categories10
Latest Approval2025-09-23
TypeNumberDevice NameCodeDate
510(k) K252043 Bipolar applicator CelonProBreath (WB990310); Bipolar applicator CelonProSleep plus (WB990311); Bipolar applicator CelonProBreath (WB990210); Bipolar applicator CelonProSleep plus (WB990211) GEI 2025-09-23 View
510(k) K231777 Electrosurgical Generator ESG-410 and Accessories (WA91327U, WA91327W), Accessories: Foot switches (WA91311W, WA91321W) GEI 2023-08-18 View
510(k) K221522 HF-cables (resusable) GEI 2023-01-19 View
510(k) K223183 Light-Guide Cables HBI 2023-01-13 View
510(k) K213207 Sheath, Stopcock Accessory HIH 2021-12-22 View
510(k) K203492 Instrument tray, for semi-rigid ureteroscope KCT 2021-09-15 View
510(k) K210651 Resection Electrodes with HF cable FAS 2021-08-03 View
510(k) K203682 Electrosurgical Generator ESG-400, Foot Switches, POWERSEAL Curved Jaw Sealer and Divider, Double Action GEI 2021-05-17 View
510(k) K203277 Electrosurgical Generator ESG-410, Foot Switches, PK Cutting Forceps GEI 2021-04-28 View
510(k) K200369 OES Elite Ureteroscopes and Accessories FGB 2020-08-28 View
510(k) K190744 ENDOEYE HD II (WA50040A, WA50042A, WA50050A, WA50052A) HET 2019-08-29 View
510(k) K182587 Device Electrosurgical Generator ESG-150 GEI 2018-11-29 View
510(k) K180200 ESG-300, APU-300, Pressure Reducer, MAPC Probes GEI 2018-04-26 View
510(k) K171692 Instrument basket, for EndoEYE KCT 2018-04-02 View
510(k) K172535 Bipolar applicator CELON ProCurve V GEI 2017-11-16 View
510(k) K171965 Resection Electrodes with HF cable FAS 2017-09-28 View
510(k) K161600 Resection Electrodes JOS 2016-09-06 View
510(k) K160053 Monopolar single-use HF cable GEI 2016-05-06 View
510(k) K160639 Electrosurgical Generator ESG-200 GEI 2016-05-04 View
510(k) K160249 ULTRA Telescopes HRX 2016-04-21 View
510(k) K153009 ULTRA Telescopes EOB 2016-04-05 View