510(k) K081184 ยท FGE Stents, Drains And Dilators For The Biliary Ducts
GORE VIABIL BILILARY ENDOPROSTHESIS
| Applicant | W.L. Gore & Associates, Inc. Medical Products Div., Flagstaff AZ, US |
| Decision | Unknown, Jul 22, 2008 |
| Received | Apr 25, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K081184
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 5, 2021 | W.L. Gore & Associates, Inc. GORE VIBIL Biliary Endoprosthesis: stents, drains and dilators for the biliary ducts. Catalogue numbers: VH1008040, VH1010040, VN1010040, VN0808200 - Product Usage: intended for palliation of malignan Terminated |
FGE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.