510(k) K152524 ยท FGE Stents, Drains And Dilators For The Biliary Ducts
Entuit Secure Gastrointestinal Suture Anchor Set, Entuit Secure Adjustable Gastrointestinal Suture Anchor Set
| Applicant | Cook Incorporated, Bloomington IN, US |
| Decision | Substantially Equivalent, Sep 30, 2015 |
| Received | Sep 3, 2015 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K152524
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 12, 2024 | Cook Incorporated Entuit Secure Adjustable Gastrointestinal Suture Anchor Set - Intended for anchoring the anterior wall of the stomach to the abdominal wall prior to introduction of interventional catheters.
REFERE Open, Classified |
FGE | None listed |
| Dec 19, 2018 | Cook Inc. Entuit Secure Gastrointestinal Suture Anchor Set, Catalog Number GIAS-SRM-2, Order Number G35569
The Entuit Secure Gastrointestinal Suture Anchor Set is intended for anchoring the anterior wall of th Terminated |
FGE | None listed |
| Dec 19, 2018 | Cook Inc. Entuit Secure Gastrointestinal Suture Anchor Set, Catalog Number GIAS-SRM-3, Order Number G35570
The Entuit Secure Gastrointestinal Suture Anchor Set is intended for anchoring the anterior wall of th Terminated |
FGE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.