510(k) K021701 ยท GDW Staple, Implantable
SURGASSIST RIGHT ANGLE LINEAR CUTTER 30MM, 45MM & 60MM, MODELS RALC30, RALC45 & RALC60
| Applicant | Power Medical Interventions, Inc., New Hope PA, US |
| Decision | Substantially Equivalent, Jun 21, 2002 |
| Received | May 23, 2002 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K021701
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 23, 2009 | Surgical Devices/Covidien Right Angle Linear Cutter, 30 mm Digital Loading Unit, product code RALC30; Right Angle Linear Cutter, 30 mm Vascular Digital Loading Unit, product code RALC30V; Right Angle Linear Cutter, 45 mm Digit Terminated |
GDW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.