# K023843: Smartstitch M-Connector, Model OM-8005; Smartstitch Actuation Handle, Model OM-8500; and Smartstitch Suture Cartridge

- Pathway: 510(k) (Traditional)
- Applicant: Opus Medical, Inc.
- Decided: Feb 14, 2003 after 88 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.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices 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.

## Most influential descendants
- 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

## Indications for use
SmartStitch Suture Device: The Opus SmartStitch M-Connector (Model #0M-8005) is indicated for use with a Actuation Handle (Model #0M-8500) and Suture Cartridges (Models #OM-8051, -8052, -8053) for placement of #2 Braided Polyester Suture through soft tissue in endoscopic and other limited access procedures. SmartStitch Sutures: The Opus Polyester Surgical Sutures are indicated for use in general soft tissue approximation and/or ligation including use in cardiovascular, ophthalmic, orthopedic, and neurological procedures.

Source page: https://510kreport.com/device/K023843
Methodology: https://510kreport.com/methodology