# K063161: Skintact Cool Contact Electrosurgical Grounding Plate with NH 04 Gel

- Pathway: 510(k) (Special)
- Applicant: Leonhard Lang GmbH
- Decided: Nov 21, 2006 after 35 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: 3 generations back to K853291 (1985). 4 ancestors in all.
14 later devices descend from it; 4 cite it directly.
3 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030362: Skintact Cool Contact Electrosurgical Grounding Plates, Leonhard Lang GmbH (2003) Summary page 1.

## Most influential descendants
- K140500: Skintact (2014), 4 descendants of its own
- K080741: Mega Soft Reusable Patient Return Electrode (2008), 4 descendants of its own
- K173877: BOWA Neutral Electrodes (2018), 3 descendants of its own
- K133726: Mega Soft Universal Patient Return Electrode (2014), 3 descendants of its own
- K091672: Disposable Grounding Pad Series and Electrode Series (2009), 3 descendants of its own

## Indications for use
Skintact Cool Contact Electrosurgical Grounding Plates are designed for use with electrosurgical generators for cutting and coagulation of human tissue.

Source page: https://510kreport.com/device/K063161
Methodology: https://510kreport.com/methodology