510(k) K254069 ยท PKL Hemostatic Metal Clip For The Gi Tract
Hemoclip (511 series, 543 series)
| Applicant | Hangzhou AGS MedTech Co., Ltd., Hangzhou, CN |
| Decision | Substantially Equivalent, Aug 10, 2026 |
| Received | Dec 18, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K254069
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.