510(k) K032701 ยท GDW Staple, Implantable
SURGASSIST CIRCULAR STAPLER DIGITAL LOADING UNITS (CS21, CS25, CS29, CS33)
| Applicant | Power Medical Interventions, Inc., New Hope PA, US |
| Decision | Substantially Equivalent, Sep 30, 2003 |
| Received | Sep 2, 2003 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K032701
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 23, 2009 | Surgical Devices/Covidien Circular Stapler 21 mm Digital Loading Unit, product code CS21; Circular Stapler 25 mm Digital Loading Unit, product code CS25; Circular Stapler 29 mm Digital Loading Unit, product code CS29; Circular Terminated |
GDW | None listed |
| Dec 19, 2003 | Power Medical Interventions SurgAssist System Circular Stapler DLU 29mm Terminated |
GWD | None listed |
| Dec 19, 2003 | Power Medical Interventions SurgAssist System Circular Stapler DLU 33mm Terminated |
GWD | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.