510(k) K081826 ยท GDW Staple, Implantable
INTELLIGENT STRAIGHT AND ARTICULAR ENDOSCOPIC LINEAR CUTTERS, VASCULAR WITH RELOADS, MODELS I30V, I45V, 160V, IR30V
| Applicant | Power Medical Interventions, Inc., Langhorne PA, US |
| Decision | Substantially Equivalent, Jul 25, 2008 |
| Received | Jun 27, 2008 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K081826
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 23, 2009 | Surgical Devices/Covidien Intelligent 60mm Articulating Endoscopic Linear Cutter, product code i60; Intelligent 60mm Articulating Endoscopic Linear Cutter Extra Long, product code i60XXL; Intelligent 45mm Articulating Endoscop Terminated |
GDW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.