Chrysalis Intelligence · Sponsors · Olympus Winter & Ibe GmbH

Olympus Winter & Ibe GmbH

Hamburg, DE · 11 510(k) clearances

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Total clearances

11

2020-08-28 → 2026-05-21

Last 12 months

2

Product codes

7

Most recent

2026-05-21

Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code	Device name	Class	Specialty	Clearances	Most recent
GEI	Electrosurgical, Cutting & Coagulation & Accessories	Class II	General, Plastic Surgery	5	2025-09-23
FAJ	Cystoscope And Accessories, Flexible/Rigid	Class II	Gastroenterology, Urology	1	2026-05-21
HBI	—	—	—	1	2023-01-13
HIH	Hysteroscope (And Accessories)	Class II	Obstetrics/Gynecology	1	2021-12-22
KCT	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories	Class II	General Hospital	1	2021-09-15
FAS	—	—	—	1	2021-08-03
FGB	—	—	—	1	2020-08-28

Filings

All 510(k) clearances (11)

Date	K-number	Device	Code	Class	Specialty
2026-05-21	K260649	OES ELITE Cystoscope and Accessories; Obturator, 17 Fr. (WA2C17BO); Obturator, 19.8 Fr. (WA2C19BO); Obturator, 21 Fr. (WA2C21BO); Obturator, 21 Fr., for sheath with ramp (WA2C21RO); Obturator, 21 Fr., long (WA2C21LO); Obturator, 21 Fr., for straight sheath (WA2C21SO); Obturator, 22.5 Fr. (WA2C22BO); Obturator, 25 Fr. (WA2C25BO); Obturator, optical, 19.8 Fr. (WA2C19BV); Obturator, optical, 21 Fr. (WA2C21BV); Obturator, optical, 21 Fr., for straight sheath (WA2C21SV); Obturator, optical,	FAJ	Class II	Gastroenterology, Urology
2025-09-23	K252043	Bipolar applicator CelonProBreath (WB990310); Bipolar applicator CelonProSleep plus (WB990311); Bipolar applicator CelonProBreath (WB990210); Bipolar applicator CelonProSleep plus (WB990211)	GEI	Class II	General, Plastic Surgery
2023-08-18	K231777	Electrosurgical Generator ESG-410 and Accessories (WA91327U, WA91327W), Accessories: Foot switches (WA91311W, WA91321W)	GEI	Class II	General, Plastic Surgery
2023-01-19	K221522	HF-cables (resusable)	GEI	Class II	General, Plastic Surgery
2023-01-13	K223183	Light-Guide Cables	HBI	—	—
2021-12-22	K213207	Sheath, Stopcock Accessory	HIH	Class II	Obstetrics/Gynecology
2021-09-15	K203492	Instrument tray, for semi-rigid ureteroscope	KCT	Class II	General Hospital
2021-08-03	K210651	Resection Electrodes with HF cable	FAS	—	—
2021-05-17	K203682	Electrosurgical Generator ESG-400, Foot Switches, POWERSEAL Curved Jaw Sealer and Divider, Double Action	GEI	Class II	General, Plastic Surgery
2021-04-28	K203277	Electrosurgical Generator ESG-410, Foot Switches, PK Cutting Forceps	GEI	Class II	General, Plastic Surgery
2020-08-28	K200369	OES Elite Ureteroscopes and Accessories	FGB	—	—