510(k) K020585 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
ZIP OPEN FORCEPS WITH ELECTROSURGICAL CUT
| Applicant | Gyrus Medical, Inc., Maple Grove MN, US |
| Decision | Substantially Equivalent, Jul 13, 2002 |
| Received | Feb 22, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K020585
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 27, 2006 | Gyrus Medical, Inc. GYRUS ACMI PKS PlasmaSEAL Open Forceps, model 2103PK and 917015PK. Sterile EO. The device is intended to be used with the PlasmaKinetic electrosurgical generator, software version 1.93 or greater or Terminated |
GEI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.