# K140658: Thermogard Dispersive Electrodes, Thermogard Plus Abc Dispersive Electrodes

- Pathway: 510(k) (Traditional)
- Applicant: Conmed Corporation
- Decided: Jul 10, 2014 after 118 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K972628 (1997). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K972628: Thermogard & Thermogard Plus Abc, Conmedcorp (1997) Summary page 2.

## Recalls of this device
- May 18, 2016 · Class II · Z-2595-2016: A version of the dual dispersive electrodes may not be compatible with some electrosurgical generators, placing patients at risk for undetected pad lift and a potential burn.
- May 18, 2016 · Class II · Z-2599-2016: A version of the dual dispersive electrodes may not be compatible with some electrosurgical generators, placing patients at risk for undetected pad lift and a potential burn.
- May 18, 2016 · Class II · Z-2598-2016: A version of the dual dispersive electrodes may not be compatible with some electrosurgical generators, placing patients at risk for undetected pad lift and a potential burn.
- May 18, 2016 · Class II · Z-2596-2016: A version of the dual dispersive electrodes may not be compatible with some electrosurgical generators, placing patients at risk for undetected pad lift and a potential burn.
- May 18, 2016 · Class II · Z-2597-2016: A version of the dual dispersive electrodes may not be compatible with some electrosurgical generators, placing patients at risk for undetected pad lift and a potential burn.

## Indications for use
The ConMed ThermoGard® and ThermoGard® Plus ABC Dispersive Electrodes are used for the dispersion and return to the electrosurgical generator of therapeutic (RF) energy introduced to the patient at the active electrode during electrosurgical procedures.

Source page: https://510kreport.com/device/K140658
Methodology: https://510kreport.com/methodology