# K033317: Smartstitch M-Connector, Model OM-8700; Needle Cassette, OM-8750; Autocuff System Instrument Set, OM-9070

- Pathway: 510(k) (Traditional)
- Applicant: Opus Medical, Inc.
- Decided: Dec 30, 2003 after 76 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
The Opus SmartStitch M-Connector is indicated for use for placement of Braided Polyester Suture through soft tissue in endoscopic and other limited access procedures. The Opus SmartStitch Needle Cassette is indicated for use for placement of Braided Polyester Suture through soft tissue in endoscopic and other limited access procedures.

Source page: https://510kreport.com/device/K033317
Methodology: https://510kreport.com/methodology