510(k) K021249 ยท GDW Staple, Implantable
SURGASSIST FLEXSHAFT 2, MODEL FS2 14
| Applicant | Power Medical Interventions, Inc., New Hope PA, US |
| Decision | Substantially Equivalent, May 15, 2002 |
| Received | Apr 19, 2002 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K021249
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 23, 2009 | Surgical Devices/Covidien FlexShaft, product code FS14; FlexShaft II, product code FS214; FlexShaft III, product code FS312; FlexShaft III Sterilization Connector Guard, product code FS3SCG; FlexShaft II Reconditioned, product Terminated |
GDW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.