# K201221: Electrosurgical Generator

- Pathway: 510(k) (Traditional)
- Applicant: New Deantronics Taiwan, Ltd.
- Decided: Sep 28, 2020 after 145 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: 2 generations back to K944602 (1995). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143161: Force FX-8(S), Force FX-8C (S), Force FX-8CA (S), Covidien (2014) Summary page 4.

## Indications for use
The Electrosurgical Generator is an electrosurgical generator containing monopolar and bipolar technology. It is intended for use with accessories during surgical procedures where the surgeon requires electrosurgical cutting and coagulating.

Source page: https://510kreport.com/device/K201221
Methodology: https://510kreport.com/methodology