510(k) K003277 ยท GDW Staple, Implantable
SURGASSIST SYSTEM WITH CIRCULAR STAPLER DISPOSABLE LOADING UNIT, MODEL CS21,CS25,CS29,CS33
| Applicant | Powermed, Inc., New Hope PA, US |
| Decision | Substantially Equivalent, Dec 21, 2000 |
| Received | Oct 19, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K003277
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 23, 2009 | Surgical Devices/Covidien SurgASSIST System Storage Cart, product code CART; SurgASSIST Service Manual, product code SRVM; SurgASSIST System Starter Kit, product code Surg200; SurgASSIST System with Integrated Controls, produc Terminated |
GDW | None listed |
| Jul 24, 2003 | Power Medical Interventions SurgASSIST System. Circular Stapler DLU 29 mm (product code CS29) Terminated |
GAG | None listed |
| Jul 24, 2003 | Power Medical Interventions SurgASSIST System. Circular Stapler DLU 33 mm (product code CS33). Terminated |
GAG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.