# K120322: Conmed Surefit Dual Dispersive Electrode

- Pathway: 510(k) (Special)
- Applicant: Conmed Corporation
- Decided: Jun 12, 2012 after 131 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K002002 (2000). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100047: Surefit Dual Dispersive Electrode, Conmed Corporation (2010) Summary page 1.

## Indications for use
CONMED® SurefitTh Dual Dispersive Electrodes are designed for use with only those electrosurgical generators equipped with contact quality monitoring systems (i.e. REMW, ARM TM, and NESSY, Tm ' etc.) during electrosurgery and provides a path for, RF energy produced at the active electrode to return to the generator. The Sureflt~4 Dual Dispersive Electrode is for use with all patient populations providing there is sufficient surface area to ensure full contact of the electrode with the patient's skin.

Source page: https://510kreport.com/device/K120322
Methodology: https://510kreport.com/methodology