# K162656: ESU-1 Electrosurgical Generator

- Pathway: 510(k) (Traditional)
- Applicant: Tva Medical, Inc.
- Decided: Nov 10, 2016 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: 5 generations back to K933002 (1994). 8 ancestors in all.
1 later device descends 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)
- K134054: Bovie Ids-310 High Frequency Electrosurgical Generator, Aaron A3350 High Frequency Electrosurgical Generator, Bovie Medical Corporation (2014) Summary page 4.

## Most influential descendants
- K222793: WavelinQ™ Generator (2022), 0 descendants of its own

## Indications for use
The ESU-1 Electrosurgical Generator is used to deliver RF energy via an assortment of surgical devices to cut and coagulate different kinds of tissue.

Source page: https://510kreport.com/device/K162656
Methodology: https://510kreport.com/methodology