510(k) K102325 ยท GDW Staple, Implantable
IDRIVE SYSTEM (I DRIVE POWER HANDLE, IDRIVE (RALC) SINGLE USE RELOAD)
| Applicant | Covidien, LLC, Formerly Registered AS Tyco Healthca, North Haven CT, US |
| Decision | Substantially Equivalent, Oct 13, 2010 |
| Received | Aug 17, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K102325
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.