# K982739: Gynex Electrodes

- Pathway: 510(k) (Traditional)
- Applicant: Gynex Corp.
- Decided: Mar 12, 1999 after 218 days
- Product code: HGI (Electrocautery, Gynecologic (And Accessories))
- Device class: 2
- Regulation: 21 CFR 884.4120
- 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 K952483 (1995). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K952483: Leep System 1000, CooperSurgical, Inc. (1995) Summary page 1.

## Indications for use
Soft tissue cutting & coagulation Intraepithelial neoplasia Condylomata acuminata Misc. lesions; polyps, molluscum contagiosum, nevi, seborrheic keratosis, achricordon, etc.

Source page: https://510kreport.com/device/K982739
Methodology: https://510kreport.com/methodology