510(k) K073001 ยท GDW Staple, Implantable
IDRIVES, IDRIVEC, IDRIVEF
| Applicant | Power Medical Interventions, Inc., Langhorne PA, US |
| Decision | Substantially Equivalent, Dec 18, 2007 |
| Received | Oct 24, 2007 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K073001
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 23, 2009 | Surgical Devices/Covidien Intelligent Delivery System, Straight, product code iDriveS; Intelligent Delivery System, Curved, product code iDriveC; Intelligent Delivery System, Flexible, product code iDriveF. Terminated |
GDW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.