# K081853: Overstitch Endoscopic Suture System

- Pathway: 510(k) (Traditional)
- Applicant: Apollo Endosurgery, Inc.
- Decided: Aug 18, 2008 after 49 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 K972679 (1997). 5 ancestors in all.
8 later devices descend from it; 1 cites it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061770: Ethicon Endo Surgery Endoscopic Suturing System, Ethicon Endo-Surgery, Inc. (2006) Summary page 1.
- K003956: Bard Endocinch Suturing System # 000452; 000454; 000595, C.R. Bard, Inc. (2001) Summary page 1.
- K972911: Auto Suture*Endostitch* II** Suture Applier, United States Surgical, A Division of Tyco Healthc (1998) Summary page 1.

## Most influential descendants
- K171886: OverStitch SX Endoscopic Suturing System (ESS) (2017), 7 descendants of its own
- K181141: OverStitch Endoscopic Suturing System and Accessories (2018), 3 descendants of its own
- K211309: endomina system (2021), 1 descendant of its own
- K210266: OverStitch Sx Endoscopic Suturing System (2021), 1 descendant of its own
- K252400: Endomina EZFuse system (2026), 0 descendants of its own

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

Source page: https://510kreport.com/device/K081853
Methodology: https://510kreport.com/methodology