510(k) K260580 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, May 21, 2026 |
| Received | Feb 20, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K260580
No recall in the FDA data names this 510(k).
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