# K251229: EndoFix™Tissue Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Softac Medical Technologies
- Decided: Aug 20, 2025 after 121 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: 8 generations back to K963160 (1997). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152524: Entuit Secure Gastrointestinal Suture Anchor Set, Entuit Secure Adjustable Gastrointestinal Suture Anchor Set, Cook Incorporated (2015) Summary page 5.
- K201808: X-Tack Endoscopic HeliX Tacking System, Apollo Endosurgery, Inc. (2020) Summary page 5.

## Indications for use
The EndoFix ™ Tissue Fixation System is an endoscopic tissue approximation system intended for anchoring the gallbladder to the stomach or duodenum to aid placement of a luminal apposing metal stent (LAMS) for EUS-guided gallbladder drainage.

Source page: https://510kreport.com/device/K251229
Methodology: https://510kreport.com/methodology