# K252400: Endomina EZFuse system

- Pathway: 510(k) (Traditional)
- Applicant: Endo Tools Therapeutics S.A.
- Decided: Feb 13, 2026 after 197 days
- Product code: OCW (Endoscopic Tissue Approximation Device)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K972679 (1997). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K211309: endomina system, Endo Tools Therapeutics S.A. (2021) Summary page 6.

## Indications for use
The endomina® EZFuse system is intended for endoscopic placement of suture(s) and approximation of soft tissue in the gastrointestinal tract.

Source page: https://510kreport.com/device/K252400
Methodology: https://510kreport.com/methodology