510(k) K101428 ยท PKL Hemostatic Metal Clip For The Gi Tract
OTSC (OVER-THE SCOPE-CLIP) SYSTEM SET
| Applicant | Ovesco Endoscopy AG, Karlsruhe, DE |
| Decision | Substantially Equivalent, Dec 1, 2010 |
| Received | May 21, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K101428
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.