Olympus Winter & Ibe GmbH
FDA 510(k) & PMA Approved 기기 — 22 products
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최신 FDA 결정
| 유형 | 번호 | 기기명 | 코드 | 날짜 | 작업 |
|---|---|---|---|---|---|
| 510(k) | 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 | 2026-05-21 | 보기 |
| 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 | 보기 |
| 510(k) | K231777 | Electrosurgical Generator ESG-410 and Accessories (WA91327U, WA91327W), Accessories: Foot switches (WA91311W, WA91321W) | GEI | 2023-08-18 | 보기 |
| 510(k) | K221522 | HF-cables (resusable) | GEI | 2023-01-19 | 보기 |
| 510(k) | K223183 | Light-Guide Cables | HBI | 2023-01-13 | 보기 |
| 510(k) | K213207 | Sheath, Stopcock Accessory | HIH | 2021-12-22 | 보기 |
| 510(k) | K203492 | Instrument tray, for semi-rigid ureteroscope | KCT | 2021-09-15 | 보기 |
| 510(k) | K210651 | Resection Electrodes with HF cable | FAS | 2021-08-03 | 보기 |
| 510(k) | K203682 | Electrosurgical Generator ESG-400, Foot Switches, POWERSEAL Curved Jaw Sealer and Divider, Double Action | GEI | 2021-05-17 | 보기 |
| 510(k) | K203277 | Electrosurgical Generator ESG-410, Foot Switches, PK Cutting Forceps | GEI | 2021-04-28 | 보기 |
| 510(k) | K200369 | OES Elite Ureteroscopes and Accessories | FGB | 2020-08-28 | 보기 |
| 510(k) | K190744 | ENDOEYE HD II (WA50040A, WA50042A, WA50050A, WA50052A) | HET | 2019-08-29 | 보기 |
| 510(k) | K182587 | Device Electrosurgical Generator ESG-150 | GEI | 2018-11-29 | 보기 |
| 510(k) | K180200 | ESG-300, APU-300, Pressure Reducer, MAPC Probes | GEI | 2018-04-26 | 보기 |
| 510(k) | K171692 | Instrument basket, for EndoEYE | KCT | 2018-04-02 | 보기 |
| 510(k) | K172535 | Bipolar applicator CELON ProCurve V | GEI | 2017-11-16 | 보기 |
| 510(k) | K171965 | Resection Electrodes with HF cable | FAS | 2017-09-28 | 보기 |
| 510(k) | K161600 | Resection Electrodes | JOS | 2016-09-06 | 보기 |
| 510(k) | K160053 | Monopolar single-use HF cable | GEI | 2016-05-06 | 보기 |
| 510(k) | K160639 | Electrosurgical Generator ESG-200 | GEI | 2016-05-04 | 보기 |
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