# K161715: EndyGel

- Pathway: 510(k) (Traditional)
- Applicant: Endymed Medical, Ltd.
- Decided: Feb 7, 2017 after 231 days
- Product code: GYB (Media, Electroconductive)
- Device class: 2
- Regulation: 21 CFR 882.1275
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K983964 (1998). 7 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111717: Electro-Gel, Electro-Cap Intl., Inc. (2012) Summary page 5.

## Most influential descendants
- K200402: DR-HO'S Electro Therapy Conductive Gel (2020), 1 descendant of its own
- K222770: Conductive Gel (2022), 0 descendants of its own

## Indications for use
EndyGel is an Electroconductive gel media used with external electrode to reduce the impedance (resistance to alternating current) of the contact between the electrode surface and the skin.

Source page: https://510kreport.com/device/K161715
Methodology: https://510kreport.com/methodology