# K131201: Entuit Secure Gastrointestional Suture Anchor Set, Entuit Secure Adjustable Gastrointestinal Suture Anchor Set

- Pathway: 510(k) (Traditional)
- Applicant: Cook, Inc.
- Decided: Oct 7, 2013 after 161 days
- Product code: FGE (Stents, Drains And Dilators For The Biliary Ducts)
- Device class: 2
- Regulation: 21 CFR 876.5010
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K873606 (1988). 2 ancestors in all.
2 later devices descend 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)
- K090133: Connex Gastrointestinal Suture Anchor, Model Gias, Cook, Inc. (2009) Summary page 2.

## Most influential descendants
- K152524: Entuit Secure Gastrointestinal Suture Anchor Set, Entuit Secure Adjustable Gastrointestinal Suture Anchor Set (2015), 1 descendant of its own
- K251229: EndoFix™Tissue Fixation System (2025), 0 descendants of its own

## 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/K131201
Methodology: https://510kreport.com/methodology