510(k) K791137 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
SINGLE USE MONOPOLAR HAND CONTROL PENCIL
| Applicant | Davol, Inc., Walker MI, US |
| Decision | Substantially Equivalent, Jul 24, 1979 |
| Received | Jun 18, 1979 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K791137
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 10, 2010 | ConMed Electrosurgery ConMed Goldline Hand Controlled With Needle Electrode, Rocker Switch, Safety Holster and 10 FT Cable, REF 130301A, Sterile R, Assembled in Mexico, ConMed Corporation, 525 French Rd., Utica, NY 13502. Terminated |
GEI | None listed |
| May 10, 2010 | ConMed Electrosurgery ConMed Goldline Hand Controlled With Blade Electrode, Tip Cleaner, Rocker Switch, Safety Holster and 10 FT Cable, REF 130304A, Sterile R, Assembled in Mexico, ConMed Corporation, 525 French Rd., Utica Terminated |
GEI | None listed |
| May 10, 2010 | ConMed Electrosurgery ConMed Goldline Hand Controlled With Blade Electrode, Rocker Switch, Safety Holster and 10 FT Cable, REF 130307A, Sterile R, Assembled in Mexico, ConMed Corporation, 525 French Rd., Utica, NY 13502. Terminated |
GEI | None listed |
| May 10, 2010 | ConMed Electrosurgery ConMed Goldline Hand Controlled With Blade Electrode, Rocker Switch, Safety Holster and 10 FT Cable, REF 130319A, Sterile R, Assembled in Mexico, ConMed Corporation, 525 French Rd., Utica, NY 13502. Terminated |
GEI | None listed |
| May 10, 2010 | ConMed Electrosurgery ConMed Goldline Hand Controlled With Blade Electrode, Rocker Switch, Safety Holster and 15 FT Cable, REF 130327A, Sterile R, Assembled in Mexico, ConMed Corporation, 525 French Rd., Utica, NY 13502. Terminated |
GEI | None listed |
| May 10, 2010 | ConMed Electrosurgery ConMed Goldline Hand Controlled With Blade Electrode, Rocker Switch, Safety Holster and 15 FT Cable, REF 130337A, Sterile R, Assembled in Mexico, ConMed Corporation, 525 French Rd., Utica, NY 13502. Terminated |
GEI | None listed |
| May 10, 2010 | ConMed Electrosurgery ConMed Goldline Hand Controlled, Rocker Switch, Safety Holster and 10 FT Cable, Bulk, REF 130339A, Non-Sterile, Assembled in Mexico, ConMed Corporation, 525 French Rd., Utica, NY 13502. Terminated |
GEI | None listed |
| May 10, 2010 | ConMed Electrosurgery ConMed Goldline Hand Controlled with UltraClean Blade Electrode, Rocker Switch, Safety Holster and 10 FT Cable, REF 131307A, Sterile R, Assembled in Mexico, ConMed Corporation, 525 French Rd., Utica, Terminated |
GEI | None listed |
| May 10, 2010 | ConMed Electrosurgery ConMed Goldline Hand Controlled with UltraClean Blade Electrode, Rocker Switch, Safety Holster and 10 FT Cable, REF 131319A, Assembled in Mexico, ConMed Corporation, 525 French Rd., Utica, NY 13502. Terminated |
GEI | None listed |
| May 10, 2010 | ConMed Electrosurgery ConMed Goldline Hand Controlled with UltraClean Blade Electrode, Rocker Switch, Safety Holster and 15 FT Cable, REF 131327A, Sterile R, Assembled in Mexico, ConMed Corporation, 525 French Rd., Utica, Terminated |
GEI | None listed |
| May 10, 2010 | ConMed Electrosurgery ClearVac Goldline Rocker Switch with Blade Electrode, REF 60-6829-001A, Sterile R, Assembled in Mexico, ConMed Corporation, 525 French Rd., Utica, NY 13502. Terminated |
GEI | None listed |
| May 10, 2010 | ConMed Electrosurgery ClearVac Goldline Rocker Switch with UltraClean Blade Electrode, REF 60-6829-005A, Sterile R, Assembled in Mexico, ConMed Corporation, 525 French Rd., Utica, NY 13502. Terminated |
GEI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.