# K091672: Disposable Grounding Pad Series and Electrode Series

- Pathway: 510(k) (Traditional)
- Applicant: Shuyou Electric Medical Science Co., Ltd.
- Decided: Dec 4, 2009 after 178 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: 4 generations back to K853291 (1985). 11 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063161: Skintact Cool Contact Electrosurgical Grounding Plate with NH 04 Gel, Leonhard Lang GmbH (2006) Summary page 1.
- K081791: E-Z Clean Electrosurgical Electrode, Megadyne Medical Products, Inc. (2008) Summary page 1.

## Most influential descendants
- K152059: Disposable General Electrode (2016), 1 descendant of its own
- K171707: GA-B, GA-C, GA-E, GA-I, GA-S, GA-W3A, GA-F3A, GA-IL, GA-SL, GA-W3B, GA-F1A (2017), 0 descendants of its own
- K160366: Electrosurgical disposable grounding pads (2016), 0 descendants of its own

## Indications for use
The Disposable Grounding Pad series devices are to conduct electrosurgical energy from target tissue of a patient back to an electrosurgical unit (ESU), or generator. The Disposable Electrode series devices are intended to conduct radio frequency (RE) current for cutting and coagulation from the electrosurgical generator to target soft tissue in a broad range of surgical procedures requiring the use of electrosurgery for cutting and cauterization.

Source page: https://510kreport.com/device/K091672
Methodology: https://510kreport.com/methodology