# K152524: Entuit Secure Gastrointestinal Suture Anchor Set, Entuit Secure Adjustable Gastrointestinal Suture Anchor Set

- Pathway: 510(k) (Special)
- Applicant: Cook Incorporated
- Decided: Sep 30, 2015 after 27 days
- Product code: FGE (Stents, Drains And Dilators For The Biliary Ducts)
- Device class: 2
- Regulation: 21 CFR 876.5010
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K873606 (1988). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131201: Entuit Secure Gastrointestional Suture Anchor Set, Entuit Secure Adjustable Gastrointestinal Suture Anchor Set, Cook, Inc. (2013) Summary page 4.

## Most influential descendants
- K251229: EndoFix™Tissue Fixation System (2025), 0 descendants of its own

## Recalls of this device
- Mar 1, 2024 · Class II · Z-1529-2024: Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility
- Dec 19, 2018 · Class II · Z-0968-2019: There is a potential for difficulty in sliding down the retention mechanism on the sets manufactured with a specific extension spring lot.
- Dec 19, 2018 · Class II · Z-0967-2019: There is a potential for difficulty in sliding down the retention mechanism on the sets manufactured with a specific extension spring lot.

## Indications for use
The Entuit Secure Gastrointestinal Suture Anchor Set is intended for anchoring the anterior wall of the stomach to the abdominal wall prior to introduction of interventional catheters. The Entuit Secure Adjustable Gastrointestinal Suture Anchor Set is intended for anchoring the anterior wall of the stomach to the abdominal wall prior to introduction of interventional catheters.

Source page: https://510kreport.com/device/K152524
Methodology: https://510kreport.com/methodology