# K030170: Reusable Smartstitch Suture Device, Models OM-8007, OM-8500

- Pathway: 510(k) (Traditional)
- Applicant: Opus Medical, Inc.
- Decided: Jul 28, 2003 after 192 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
No predicates in its family tree.
4 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K062244: Opus Smartstich Suture Device with Perfectpasser Connector (2006), 3 descendants of its own
- K121306: Smartstitch M-Connector Ultra Smartstitch Suture Device Handle Smartstitch Suture Device Handle (2012), 1 descendant of its own
- K163142: SpeedStitch Suture Passer; SpeedStitch Suture Cartridges, White Suture, Blue Cobraid, Black Cobraid, Mixed Pack; SpeedStitch Needle Loader and Unloader (2017), 0 descendants of its own
- K070671: Opus Smartstitch Suture Device (2007), 0 descendants of its own

## Indications for use
SmartStitch M-Connector The Opus SmartStitch M-Connector is indicated for use with a OM-8000 Actuation Handle for placement of #2 Braided Polyester Suture through soft tissue in endoscopic and other limited access procedures. SmartStitch Actuation Handle The Opus SmartStitch Actuation Handle is indicated for use with a OM-8007 M-Connector for placement of USP size #2 braided polyester suture (not supplied) through soft tissue in endoscopic and other limited access procedures.

Source page: https://510kreport.com/device/K030170
Methodology: https://510kreport.com/methodology