510(k) K112522 ยท FGE Stents, Drains And Dilators For The Biliary Ducts
FLEXSTENT BILIARY SELF-EXPANDING STENT SYSTEM
| Applicant | Flexible Stenting Solutions, Inc., Eatontown NJ, US |
| Decision | Unknown, Dec 30, 2011 |
| Received | Aug 31, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K112522
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 6, 2013 | Cordis Corporation FLEXSTENT Biliary Self-Expanding Stent System.
Product Usage:
The FSS FLEXSTENT Biliary SES product is indicated for use in the palliation of malignant strictures in the biliary tree. Terminated |
FGE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.