510(k) K240617 ยท PKL Hemostatic Metal Clip For The Gi Tract
Single Use Reloadable Clip Applicator (HX-810LR, HX-810UR); Clip (HX-610-090, HX-610-135); Long Clip (HX-610-090L, HX-610-135L); Short Clip (HX-610-090S, HX-610-135S); Super Short Clip (HX-610-135XS)
| Applicant | Olympus Medical Systems Corp., Hachioji-Shi, JP |
| Decision | Substantially Equivalent, Jun 3, 2024 |
| Received | Mar 5, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K240617
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.