# K965243: Endocare Electrosurgical Electrode

- Pathway: 510(k) (Traditional)
- Applicant: Endocare, Inc.
- Decided: Feb 25, 1997 after 64 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 K954321 (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)
- K954321: Endocare Monopolar Electrodes (Modification), Cytocare, Inc. (1995) Summary page 1.

## Indications for use
The ENDOcare Electrosurgical Electrodes are designed for use in general surgery, urology, gynecology and orthopedics for cutting, coagulation, resection and vaporization of tissue including BPH (Benign Prostatic Hyperplasia), tumors, fibroids, cysts and obstructive tissue.

Source page: https://510kreport.com/device/K965243
Methodology: https://510kreport.com/methodology