510(k) K023843 ยท OCW Endoscopic Tissue Approximation Device
SMARTSTITCH M-CONNECTOR, MODEL OM-8005; SMARTSTITCH ACTUATION HANDLE, MODEL OM-8500; AND SMARTSTITCH SUTURE CARTRIDGE
| Applicant | Opus Medical, Inc., San Juan Capistrano CA, US |
| Decision | Substantially Equivalent, Feb 14, 2003 |
| Received | Nov 18, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K023843
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.