510(k) K024286 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
GYRUS OPEN FORCEPS
| Applicant | Gyrus Medical, Inc., Minneapolis MN, US |
| Decision | Substantially Equivalent, Nov 17, 2003 |
| Received | Dec 23, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K024286
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 14, 2010 | Gyrus ACMI Corporation Gyrus ACMI PKS Seal Open Forceps, model 3103PK, 9-3/4" curved. Sterile EO. The device is intended to be used with the PlasmaKinetic electrosurgical generator, software version 1.61 or greater requir Terminated |
GEI | None listed |
| Jan 14, 2010 | Gyrus ACMI Corporation Gyrus ACMI PKS Seal Open Forceps, model 3104PK, 9-3/4" straight. Sterile EO. The device is intended to be used with the PlasmaKinetic electrosurgical generator, software version 1.61 or greater requ Terminated |
GEI | None listed |
| Jan 14, 2010 | Gyrus ACMI Corporation Gyrus ACMI PKS Seal Open Forceps, model 3104PK, 9-3/4" angled. Sterile EO. The device is intended to be used with the PlasmaKinetic electrosurgical generator, software version 1.61 or greater requir Terminated |
GEI | None listed |
| Jan 14, 2010 | Gyrus ACMI Corporation Gyrus ACMI PKS Seal Open Forceps, model 915000PK, 9-3/4" Curved Jaw. Sterile EO. The device is intended to be used with the G400 electrosurgical generator. Gyrus ACMI, Inc., 136 Turnpike Road, Sou Terminated |
GEI | None listed |
| Jan 14, 2010 | Gyrus ACMI Corporation Gyrus ACMI PKS Seal Open Forceps, model 915005PK, 9-3/4" Straight Jaw. Sterile EO. The device is intended to be used with the G400 electrosurgical generator. Gyrus ACMI, Inc., 136 Turnpike Road, S Terminated |
GEI | None listed |
| Jan 14, 2010 | Gyrus ACMI Corporation Gyrus ACMI PKS Seal Open Forceps, model 915010PK, 9-3/4" Angled Jaw. Sterile EO. The device is intended to be used with the G400 electrosurgical generator. Gyrus ACMI, Inc., 136 Turnpike Road, Sout Terminated |
GEI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.