510(k) K140658 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
THERMOGARD DISPERSIVE ELECTRODES, THERMOGARD PLUS ABC DISPERSIVE ELECTRODES
| Applicant | Conmed Corporation, Utica NY, US |
| Decision | Substantially Equivalent, Jul 10, 2014 |
| Received | Mar 14, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K140658
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 18, 2016 | Conmed Corporation Adult ThermoGard Dual Dispersive Electrodes (for patients >15 kg.), 10' (3.05m) Cable, Catalog Number 51-7310.
Intended to be used for the dispersion and return to the electrosurgical generator. Terminated |
GEI | None listed |
| May 18, 2016 | Conmed Corporation Adult ThermoGard Dual Dispersive Electrodes (for patients >15 kg.), No Cable, Catalog Number 51-7410.
Intended to be used for the dispersion and return to the electrosurgical generator. Terminated |
GEI | None listed |
| May 18, 2016 | Conmed Corporation Pediatric ThermoGard Dual Dispersive Electrodes (for patients 5-15 kg.), 10' (3.05m) Cable, Catalog Number 51-7710.
Intended to be used for the dispersion and return to the electrosurgical generator. Terminated |
GEI | None listed |
| May 18, 2016 | Conmed Corporation Adult Dual Dispersive Electrodes (for patients >15 kg.), use with the Birtcher Pad Sensing System (PSS) on the Birtcher Systems 6000, 6400, 6500 and CONMED Systems 7500 and 7550 ABC generators or conv Terminated |
GEI | None listed |
| May 18, 2016 | Conmed Corporation Pediatric Dual Dispersive Electrodes (for patients 5-15 kg.), use with the Birtcher Pad Sensing System (PSS) on the Birtcher Systems 6000, 6400, 6500 and CONMED Systems 7500 and 7550 ABC generators or Terminated |
GEI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.