510(k) K043594 ยท NLM Laparoscope, General & Plastic Surgery, Reprocessed
VANGUARD REPROCESSED BLADED TROCAR, NON-BLADED TROCAR, TROCAR ACCESSORIES
| Applicant | Vanguard Medical Concepts, Inc., Lakeland FL, US |
| Decision | Substantially Equivalent, Mar 31, 2005 |
| Received | Dec 29, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K043594
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 8, 2007 | Ascent Healthcare Solutions, Inc. AutoSuture Bladed Trocar, equipped with safety shield. Model number 179094. Available with smooth or threaded sleeve in sizes 5-15mm inner diameter and 70-100mm length. Terminated |
NLM | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.