510(k) K993785 ยท GDW Staple, Implantable
ULTRACLIP TISSUE MARKER
| Applicant | Inrad, Kentwood MI, US |
| Decision | Substantially Equivalent, Feb 4, 2000 |
| Received | Nov 8, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K993785
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 8, 2013 | Bard Peripheral Vascular Inc BARD Biopsy Systems UltraClip Dual Trigger breast tissue marker.
Intended for use to attach to soft breast tissue at the surgical site during an open surgical breast biopsy. Terminated |
FZP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.