# K100047: Surefit Dual Dispersive Electrode

- Pathway: 510(k) (Special)
- Applicant: Conmed Corporation
- Decided: May 14, 2010 after 126 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: 1 generation back to K002002 (2000). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002002: Surefit Dispersive Electrode, Conmedcorp (2000) Summary page 1.

## Most influential descendants
- K120322: Conmed Surefit Dual Dispersive Electrode (2012), 0 descendants of its own

## Indications for use
CONMED® SurefitTm Dual Dispersive Electrodes are designed for use with only those electrosurgical generators equipped with contact quality monitoring systems (i.e. REMTMI ARMm and NESSY, TMetc.) during electrosurgery and provides a path for, RF energy produced at the active electrode to return to the generator. The SurefitTm 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/K100047
Methodology: https://510kreport.com/methodology