# K003102: Pare Endoscopic Suturing System

- Pathway: 510(k) (Traditional)
- Applicant: Pare Surgical, Inc.
- Decided: Feb 27, 2001 after 146 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: 3 generations back to K972679 (1997). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K953123: Quik-Stitch, Coral Medical, Inc. (1995) Summary page 4.
- K994290: Bard Endoscopic Suturing System, C.R. Bard, Inc. (2000) Summary page 4.

## Indications for use
The PARE Endoscopic Suturing System will allow the surgical physician to suture soft tissue when doing gastroenterological procedures using the operating channel of a flexible endoscope.

Source page: https://510kreport.com/device/K003102
Methodology: https://510kreport.com/methodology