# K211309: endomina system

- Pathway: 510(k) (Traditional)
- Applicant: Endo Tools Therapeutics S.A.
- Decided: Dec 7, 2021 after 221 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: 4 generations back to K972679 (1997). 7 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171886: OverStitch SX Endoscopic Suturing System (ESS), Apollo Endosurgery, Inc. (2017) Summary page 4.

## Most influential descendants
- K252400: Endomina EZFuse system (2026), 0 descendants of its own

## Indications for use
The endomina® system, composed of a triangulation platform (endomina® platform) and an instrument for tissue piercing and approximation (TAPES), is intended for endoscopic placement of suture(s) and approximation of soft tissue in the gastrointestinal tract. The system is to be used on an adult population.

Source page: https://510kreport.com/device/K211309
Methodology: https://510kreport.com/methodology