Hemoclip (511 series)
by Hangzhou AGS MedTech Co., Ltd.
510(k) K254069
Hemoclip (511 series) is a Class II device made by Hangzhou AGS MedTech Co., Ltd., cleared under FDA 510(k) K254069 on 10 Aug 2026, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK254069 | Date10 Aug 2026 | StatusActive |
Official records
- FDA 510(k) database K254069
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- PKL
- Device class
- Class II
- Regulation
- 21 CFR Part 876.4400
- Advisory committee
- Gastroenterology, Urology
- FDA decision
- SESE Substantially Equivalent
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- Disposable Hemoclip (AF series) by Alton (Shanghai) Medical Instruments Co., Ltd.