510(k) K042031 ยท GAT Suture, Nonabsorbable, Synthetic, Polyethylene
OPUS SPEEDSTITCH SUTURE DEVICE
| Applicant | Opus Medical, Inc., San Juan Capistrano CA, US |
| Decision | Substantially Equivalent, Oct 19, 2004 |
| Received | Jul 28, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K042031
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 11, 2012 | Innovatech Medical Resources L.P. OPUS SpeedStitch Product Number OM-8086 is a suture cartridge
For use in approximation and/or ligation of soft tissues, including use of allograft tissue for orthopedic surgeries. Terminated |
GAT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.