# K191439: OverStitch 2-0 Polypropylene Suture

- Pathway: 510(k) (Traditional)
- Applicant: Apollo Endosurgery
- Decided: Aug 29, 2019 after 91 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: 5 generations back to K972679 (1997). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181141: OverStitch Endoscopic Suturing System and Accessories, Apollo Endosurgery (2018) Summary page 4.

## 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/K191439
Methodology: https://510kreport.com/methodology