510(k) K070671 ยท OCW Endoscopic Tissue Approximation Device
OPUS SMARTSTITCH SUTURE DEVICE
| Applicant | Arthrocare Corp., Irvine CA, US |
| Decision | Substantially Equivalent, Apr 6, 2007 |
| Received | Mar 12, 2007 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K070671
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 11, 2012 | Innovatech Medical Resources L.P. OPUS SmartStitch Product Number OM-8178 is a suture cartridge
For use in approximation and/or ligation of soft tissues, including use of allograft tissue for orthopedic surgeries. Terminated |
KOG | None listed |
| Jan 11, 2012 | Innovatech Medical Resources L.P. OPUS SmartStitch M-Connector Product Number OM-8007 is a suture passer Terminated |
KOG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.