510(k) K041285 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
GYRUS G3 SYSTEM (GENERATOR, ASSESSORIES, SOMNOPLASTY ELECTRODES AND PLASMACISION ELECTRODES)
| Applicant | Gyrus Medical , Ltd., Cardiff, Wales, GB |
| Decision | Substantially Equivalent, Sep 10, 2004 |
| Received | May 13, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K041285
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 30, 2010 | Gyrus Acmi, Incorporated GYRUS ACMI, dissector PlasmaKnife" , REF 7035-3005, Rx only, STERILE R, CE 0344, 161416-CA, MANUFACTURED FOR; GYRUS ACMI, INC., 136 TURNPIKE ROAD, SOUTHBOROUGH, MA 01722-2104, USA, EC REP, GYRUS ME Terminated |
GEI | None listed |
| Nov 5, 2008 | Gyrus ACMI Corporation Gyrus ACMI, Inc. dissector PlasmaKnife (DPK)
Catalog No: 7035-3005
A single use only bipolar electrosurgical instrument with the ability to cut and coagulate soft tissue in head and neck surgery with Terminated |
GEI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.