510(k) K091215 ยท GDW Staple, Implantable
INTELLIGENT POWER UNIT, INTELLIGENT CONSOLE, INTELLIGENT DELIVERY SYSTEM, INTELLIGENT SURGICAL INSTRUMENT
| Applicant | Power Medical Interventions, Inc., Langhorne PA, US |
| Decision | Substantially Equivalent, May 18, 2009 |
| Received | Apr 27, 2009 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K091215
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 23, 2009 | Surgical Devices/Covidien Intelligent Battery Pack, product code iB100; Intelligent Battery Charger and Power Supply, product code iB1C1; Intelligent Battery Insertion Guide, product code iBIG-1; Intelligent Battery Insertion Terminated |
GDW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.