# K100686: Conmed Macrolyte Dispersive Electrode

- Pathway: 510(k) (Special)
- Applicant: Conmed Corporation
- Decided: May 21, 2010 after 72 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 K954633 (1995). 1 ancestor in all.
3 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K954633: Conmed Electrosurgical Grounding Pad, Conmedcorp (1995) Summary page 1.

## Most influential descendants
- K120476: Macrolyte Dispersive Electrode (2012), 1 descendant of its own
- K132136: Single Use Grounding Pad (2013), 0 descendants of its own
- K121268: Wandy Dispersvie Electrode (2012), 0 descendants of its own

## Indications for use
CONMEDO Macrolyte®)Dispersive Electrodes are designed for use with electrosurgical generators during electrosurgery and provide a path for, RF energy produced at the active electrode to return to the generator. The CONMED® Macrolyte® 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/K100686
Methodology: https://510kreport.com/methodology