The following data is part of a premarket notification filed by Cook Incorporated with the FDA for Entuit Secure Gastrointestinal Suture Anchor Set, Entuit Secure Adjustable Gastrointestinal Suture Anchor Set.
| Device ID | K152524 |
| 510k Number | K152524 |
| Device Name: | Entuit Secure Gastrointestinal Suture Anchor Set, Entuit Secure Adjustable Gastrointestinal Suture Anchor Set |
| Classification | Stents, Drains And Dilators For The Biliary Ducts |
| Applicant | COOK INCORPORATED 750 DANIELS WAY Bloomington, IN 47404 |
| Contact | Erum B. Nasir |
| Correspondent | Erum B. Nasir COOK INCORPORATED 750 DANIELS WAY Bloomington, IN 47404 |
| Product Code | FGE |
| CFR Regulation Number | 876.5010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-09-03 |
| Decision Date | 2015-09-30 |
| Entuit Secure Gastrointestinal Suture Anchor Set | Cook Inc. | 2018-12-19 |