510(k) K053585 ยท NLM Laparoscope, General & Plastic Surgery, Reprocessed
VANGUARD REPROCESSED SUTURE PASSER
| Applicant | Ascent Healthcare Solutions, Phoenix AZ, US |
| Decision | Substantially Equivalent, Oct 11, 2006 |
| Received | Dec 23, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K053585
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 19, 2008 | Ascent Healthcare Solutions, Inc. Inlet Medical Suture Passer - Reprocessed Sterile device -- Endoscope and accessories. Terminated |
NLM | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.