510(k) K022229 ยท OCW Endoscopic Tissue Approximation Device
SMARTSTITCH SUTURE DEVICE, MODEL OM-8500
| Applicant | Opus Medical, Inc., San Juan Capistrano CA, US |
| Decision | Substantially Equivalent, Sep 6, 2002 |
| Received | Jul 10, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K022229
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 2, 2006 | ArthroCare Corporation OPUS SpeedStitch Suture Cartridge with Magnumwire, a component of the OPUS MiniPlus Implant Set, for use in placement of sutures through soft tissue in endoscopic and other limited access procedures. Terminated |
KOG | None listed |
| Jun 27, 2006 | ArthroCare Corporation ArthroCare brand OPUS Smartstitch Suture Cartridge, Catalog Number: OM-8071;
Product is distributed by ArthroCare Corporation, 680 Vaqueros Ave., Sunnyvale, CA 94085 Terminated |
KOG | None listed |
| Jun 27, 2006 | ArthroCare Corporation ArthroCare brand OPUS Smartstitch Magnum Wire Suture Cartridge, Catalog Number: OM-8075;
Product is distributed by ArthroCare Corporation, 680 Vaqueros Ave., Sunnyvale, CA 94085 Terminated |
KOG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.