# K022229: Smartstitch Suture Device, Model OM-8500

- Pathway: 510(k) (Traditional)
- Applicant: Opus Medical, Inc.
- Decided: Sep 6, 2002 after 58 days
- Product code: OCW (Endoscopic Tissue Approximation Device)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Recalls of this device
- Jun 28, 2006 · Not classified · Z-1312-06: The product may lose sterility due to omission of the final pouch seal.
- Jun 7, 2006 · Not classified · Z-1186-06: Potential loss of product sterility due to breach of pouch seal.
- Jun 7, 2006 · Not classified · Z-1187-06: Potential loss of product sterility due to breach of pouch seal.

## Indications for use
The Opus SmartStitch Suture Device is indicated for use for placement of #2 Braided Polyester Suture (such as Genzyme Polydek®) through soft tissue in endoscopic and other limited access procedures.

Source page: https://510kreport.com/device/K022229
Methodology: https://510kreport.com/methodology