# K970987: Electrosurgical Electrode

- Pathway: 510(k) (Traditional)
- Applicant: Fusion Medical Technologies, Inc.
- Decided: May 5, 1997 after 48 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 K923332 (1992). 1 ancestor in all.
118 later devices descend from it; 1 cites it directly.
0 of 120 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K923332: Electrosurgical Electrodes, Premier Dental Products Co. (1992) Summary page 2.

## Most influential descendants
- K992931: Non-Stick Bipolar Forceps (1999), 117 descendants of its own
- K011722: Atricure Bipolar Coagulation System (2001), 92 descendants of its own
- K020919: Atricure Bipolar System, Models ASU1, ASU2, ASU3, LHP1, LHP2, RHP1 (2002), 90 descendants of its own
- K040690: Surgifrost 10 CM Cryosurgical Device Plus Frostbyte Clamp and Cryosurgical Console (2004), 42 descendants of its own
- K031247: Cardioblate Bipolar Radiofrequency Surgical Ablation System (2003), 34 descendants of its own

## Indications for use
Intended for use by practitioners in a manner identical to similar electrosurgical electrodes of this type presently in commercial distribution. It is intended to provide electrocautery over a large surface.

Source page: https://510kreport.com/device/K970987
Methodology: https://510kreport.com/methodology