510(k) K123601 ยท PKL Hemostatic Metal Clip For The Gi Tract
SINGLE USE REPOSITIONABLE CLIP
| Applicant | Olympus Medical Systems Corp., Center Valley PA, US |
| Decision | Substantially Equivalent, Apr 29, 2013 |
| Received | Nov 21, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K123601
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 21, 2023 | Olympus Corporation of the Americas Single Use Repositionable Clip QUICKCLIP PRO 165 CM 10/BX- Intended for hemostatic metal clip for the GI Tract
Catalog Number: HX-202LR.A Open, Classified |
PKL | None listed |
| Jun 21, 2023 | Olympus Corporation of the Americas Single Use Repositionable Clip QUICKCLIP PRO 165CM 5/BX- Intended for hemostatic metal clip for the GI Tract
Catalog Number: HX-202LR.B Open, Classified |
PKL | None listed |
| Jun 21, 2023 | Olympus Corporation of the Americas Single Use Repositionable Clip QUICKCLIP PRO 230 CM 10/BX- Intended for hemostatic metal clip for the GI Tract
Catalog Number: HX-202UR.A Open, Classified |
PKL | None listed |
| Jun 21, 2023 | Olympus Corporation of the Americas Single Use Repositionable Clip QUICKCLIP PRO 230CM 5/BX- Intended for hemostatic metal clip for the GI Tract
Catalog Number: HX-202UR.B Open, Classified |
PKL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.