510(k) K260487 ยท PKL Hemostatic Metal Clip For The Gi Tract
stentFIX System Set (100.50n)
| Applicant | Ovesco Endoscopy AG, Tuebingen, DE |
| Decision | Substantially Equivalent, Oct 2, 2026 |
| Received | Feb 13, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K260487
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.