510(k) K012216 ยท FGE Stents, Drains And Dilators For The Biliary Ducts
NIROYAL BILIARY PREMOUNTED STENT SYSTEM
| Applicant | Boston Scientific Scimed, Inc., Maple Grove MN, US |
| Decision | Unknown, Aug 17, 2001 |
| Received | Jul 16, 2001 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K012216
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.