510(k) K020343 ยท GDW Staple, Implantable
SURGASSIST SYSTEM; WIRELESS REMOTE CONTROL (COMPONENT); WIRED REMOTE CONTROL
| Applicant | Power Medical Interventions, Inc., New Hope PA, US |
| Decision | Substantially Equivalent, Apr 10, 2002 |
| Received | Feb 1, 2002 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K020343
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 23, 2009 | Surgical Devices/Covidien Remote Control Unit with Wire, product code RCW100. Terminated |
GDW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.