# K201744: Su2ura Approximation Device

- Pathway: 510(k) (Traditional)
- Applicant: Anchora Medical, Ltd.
- Decided: Jun 17, 2021 after 357 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: 2 generations back to K934738 (1994). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082659: Modified Endo Stich, Covidien Lp, Formerly Registered AS United States (2008) Summary page 4.

## Indications for use
The Su2ura® Approximation Device is indicated in endoscopic surgery for the placement of interrupted or running stitches in soft tissue.

Source page: https://510kreport.com/device/K201744
Methodology: https://510kreport.com/methodology