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Olympus Winter & Ibe GmbH FDA Approvals
0 new drug approvals and 10 device clearances on file. Matched by name to OLYMY.
Newest first
A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.
| Product |
|---|
| 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,510(k)May 21, 2026Gastroenterology, Urology |
| Bipolar applicator CelonProBreath (WB990310); Bipolar applicator CelonProSleep plus (WB990311); Bipolar applicator CelonProBreath (WB990210); Bipolar applicator CelonProSleep plus (WB990211)510(k)Sep 23, 2025General, Plastic Surgery |
| Electrosurgical Generator ESG-410 and Accessories (WA91327U, WA91327W), Accessories: Foot switches (WA91311W, WA91321W)510(k)Aug 18, 2023General, Plastic Surgery |
| HF-cables (resusable)510(k)Jan 19, 2023General, Plastic Surgery |
| Light-Guide Cables510(k)Jan 13, 2023General, Plastic Surgery |
| Sheath, Stopcock Accessory510(k)Dec 22, 2021Obstetrics/Gynecology |
| Instrument tray, for semi-rigid ureteroscope510(k)Sep 15, 2021General Hospital |
| Resection Electrodes with HF cable510(k)Aug 3, 2021Gastroenterology, Urology |
| Electrosurgical Generator ESG-400, Foot Switches, POWERSEAL Curved Jaw Sealer and Divider, Double Action510(k)May 17, 2021General, Plastic Surgery |
| Electrosurgical Generator ESG-410, Foot Switches, PK Cutting Forceps510(k)Apr 28, 2021General, Plastic Surgery |