510(k) K093279 ยท GCJ Laparoscope, General & Plastic Surgery
NAVIX ACCESS DEVICE
| Applicant | Xlumena, Mountain View CA, US |
| Decision | Substantially Equivalent, Apr 7, 2010 |
| Received | Oct 20, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K093279
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 9, 2013 | Xlumena, Inc. Xlumena brand NAVIX Access Device, Model/Catalogue Number: NVX-10-03, Part Number: FG-00666, Product is manufactured and distributed by Xlumena, Inc., Mountain View, CA
The NAVIX Access Device is a m Terminated |
GCJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.