510(k) K253481 ยท PKL Hemostatic Metal Clip For The Gi Tract
colonic FTRD Set (200.70); diagnostic FTRD Set (200.76); gastroduodenal FTRD Set (200.72)
| Applicant | Ovesco Endoscopy AG, Tuebingen, DE |
| Decision | Substantially Equivalent, Sep 14, 2026 |
| Received | Oct 14, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253481
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.