# K231553: OverStitch NXT Endoscopic Suturing System

- Pathway: 510(k) (Special)
- Applicant: Apollo Endosurgery, Inc.
- Decided: Jun 29, 2023 after 30 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: 6 generations back to K972679 (1997). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210266: OverStitch Sx Endoscopic Suturing System, Apollo Endosurgery, Inc. (2021) Summary page 4.

## Indications for use
The OverStitch NXT Endoscopic Suturing System is intended for endoscopic placement of suture(s) and approximation of soft tissue.

Source page: https://510kreport.com/device/K231553
Methodology: https://510kreport.com/methodology