510(k) K071708 ยท GDW Staple, Implantable
I45, I45S, I60, AND I60S
| Applicant | Power Medical Interventions, Inc., Langhorne PA, US |
| Decision | Substantially Equivalent, Sep 27, 2007 |
| Received | Jun 21, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K071708
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 23, 2009 | Surgical Devices/Covidien Intelligent Reload, 45 mm Blue, product code iR45B; Intelligent Reload, 45 mm Green, product code iR45G; Intelligent Reload Mid Cut 45mm Blue, product code iR45MB; Intelligent Reload Mid Cut 45mm Gree Terminated |
GDW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.