# K062244: Opus Smartstich Suture Device with Perfectpasser Connector

- Pathway: 510(k) (Special)
- Applicant: Arthrocare Corp.
- Decided: Oct 2, 2006 after 60 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: 1 generation back to K030170 (2003). 1 ancestor in all.
3 later devices descend from it; 2 cite 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)
- K030170: Reusable Smartstitch Suture Device, Models OM-8007, OM-8500, Opus Medical, Inc. (2003) Summary page 1.

## 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
- K070671: Opus Smartstitch Suture Device (2007), 0 descendants of its own

## Indications for use
The Opus® SmartStitch™ Suture Device with PerfectPasser™ Connector is indicated for use for placement of braided polyester and polyethylene suture through soft tissue in endoscopic and other limited access procedures.

Source page: https://510kreport.com/device/K062244
Methodology: https://510kreport.com/methodology