# K980171: Dermasense Plus Dispersive Electrode

- Pathway: 510(k) (Traditional)
- Applicant: Horizon Medical, Inc.
- Decided: Feb 27, 1998 after 38 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Valleylab, Inc. REM PolyHesive II Patient Return Electrode: named in the summary without a submission number
- (no number) ConMed Corporation ThermoGard PLUS ABC Dual Dispersive Electrode: named in the summary without a submission number

## Indications for use
A NEUTRAL ELECTRODE AT WHICH NO SURGICAL EFFECT IS INTENDED WHICH PROVIDE A RETURN PATH FOR ELECTRICAL CURRENT TO GENERATOR.

Source page: https://510kreport.com/device/K980171
Methodology: https://510kreport.com/methodology