# K200931: RF Surgical Generator

- Pathway: 510(k) (Traditional)
- Applicant: Fulwell, LLC
- Decided: Nov 24, 2020 after 231 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 K933157 (1994). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013255: Surgitron 120 Iec (Also Known as Surgitron 4.0 Dual RF, Ellman Intl., Inc. (2001) Summary page 4.

## Indications for use
RF Surgical Generator FW-120A 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/K200931
Methodology: https://510kreport.com/methodology