510(k) K131201 ยท FGE Stents, Drains And Dilators For The Biliary Ducts
ENTUIT SECURE GASTROINTESTIONAL SUTURE ANCHOR SET, ENTUIT SECURE ADJUSTABLE GASTROINTESTINAL SUTURE ANCHOR SET
| Applicant | Cook, Inc., Bloomington IN, US |
| Decision | Substantially Equivalent, Oct 7, 2013 |
| Received | Apr 29, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K131201
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.