510(k) K102764 ยท PKL Hemostatic Metal Clip For The Gi Tract
RESOLUTION II CLIP
| Applicant | Boston Scientific Corporation, Marlboro MA, US |
| Decision | Substantially Equivalent, Dec 22, 2010 |
| Received | Sep 24, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K102764
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 22, 2011 | Boston Scientific Corporation The Resolution II Clip, 155 cm size and 235 cm size, Boxes of 1, 10, and 20 clips consists of a pre-loaded, radiopaque single use clip on a flexible delivery system.
Endoscopic Clipping Device, Hemo Terminated |
FHN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.