510(k) K020719 ยท GDW Staple, Implantable
SURGASSIST SYSTEM STRAIGHT LINEAR CUTTER DIGITAL LOADING UNIT, 55MM, 30MM WITH BLUE AND GREEN RELOAD CARTRIDGES
| Applicant | Power Medical Interventions, Inc., New Hope PA, US |
| Decision | Substantially Equivalent, May 10, 2002 |
| Received | Mar 5, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K020719
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 23, 2009 | Surgical Devices/Covidien Straight Linear Cutter 55 mm Blue Digital Loading Unit, product code SLC55B; Straight Linear Cutter 55 mm Green Digital Loading Unit, product code SLC55G; Straight Linear Cutter 55 mm Blue Reload, pro Terminated |
GDW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.