# K243750: SimpleStitch Suturing System

- Pathway: 510(k) (Traditional)
- Applicant: Envision Endoscopy
- Decided: Apr 17, 2025 after 133 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: 4 generations back to K972679 (1997). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 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 5.

## Indications for use
The SimpleStitch Suturing System is intended for endoscopic placement of suture(s) and approximation of soft tissue (e.g., closure and healing of ESD/EMR sites, and closing of fistula, perforation or leaks).

Source page: https://510kreport.com/device/K243750
Methodology: https://510kreport.com/methodology