# K181141: OverStitch Endoscopic Suturing System and Accessories

- Pathway: 510(k) (Special)
- Applicant: Apollo Endosurgery
- Decided: Jun 27, 2018 after 57 days
- Product code: OCW (Endoscopic Tissue Approximation Device)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: 2 (0 Class I)
- 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.
3 later devices descend from it; 2 cite it directly.
0 of 11 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
- K210266: OverStitch Sx Endoscopic Suturing System (2021), 1 descendant of its own
- K231553: OverStitch NXT Endoscopic Suturing System (2023), 0 descendants of its own
- K191439: OverStitch 2-0 Polypropylene Suture (2019), 0 descendants of its own

## Recalls of this device
- Jul 14, 2026 · Class II · Z-2961-2026: Device may fail to deploy the cinch implant and/or fail to cut the suture as intended.
- Jul 14, 2026 · Class II · Z-2962-2026: Device may fail to deploy the cinch implant and/or fail to cut the suture as intended.

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

Source page: https://510kreport.com/device/K181141
Methodology: https://510kreport.com/methodology