OTSCneo System Set (100.03n-14n, 100.27n-31n)
FDA 510(k) clearance K251562 · decided 2025-12-18
Clearance details
- K-number
- K251562
- Device name
- OTSCneo System Set (100.03n-14n, 100.27n-31n)
- Applicant
- Ovesco Endoscopy AG
- Decision
- Substantially Equivalent
- Date received
- 2025-05-22
- Decision date
- 2025-12-18
- Days to decision
- 210 days
- Clearance type
- Traditional
- Product code
- PKL
- Device class
- 2
- Regulation number
- 876.4400
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Tuebingen, DE
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|
| Single Use Reloadable Clip Applicator (HX-810LR, HX-810UR); Clip (HX-610-090, HX-610-135); Long Clip (HX-610-090L, HX-610-135L); Short Clip (HX-610-090S, HX-610-135S); Super Short Clip (HX-610-135XS) (K260580) | Olympus Medical Systems Corp. | 2026-05-21 |
| Hemoclip (K252270) | Hangzhou AGS MedTech Co., Ltd. | 2026-04-08 |
| Taurus Clip (K253734) | Taurus Endoscopy | 2026-03-12 |
| Hemoclip (K252271) | Hangzhou AGS MedTech Co., Ltd. | 2025-11-12 |
| Dual Action Tissue Closure Device (K250229) | Micro-Tech (Nanjing) Co., Ltd. | 2025-09-08 |
| PADLOCK CLIP EFTR Kit (00713229) (K250842) | STERIS Corporation | 2025-04-18 |
| Resolution Clip (M00522600); Resolution Clip (M00522601); Resolution Clip (M00522602); Resolution Clip (M00522610); Resolution Clip (M00522611); Resolution Clip (M00522612) (K250066) | Boston Scientific Corporation | 2025-02-06 |
| Haemostasis Clips (K241005) | Jiangxi Zhuoruihua Medical Instrument Co., Ltd. | 2025-01-02 |
| PADLOCK CLIP EFTR Kit (00713229) (K240274) | STERIS Corporation | 2024-09-17 |
| BARS Set (100.60) (K241858) | Ovesco Endoscopy AG | 2024-08-26 |
| Single Use Hemoclips (K234124) | Promisemed Hangzhou Meditech Co., Ltd. | 2024-07-12 |
| Disposable Hemostatic Clips (K232969) | Ningbo Xinwell Medical Technology Co., Ltd. | 2024-06-07 |
Recalls involving this device
No recalls on record reference this clearance.