# K183564: Electrosurgical Generator

- Pathway: 510(k) (Traditional)
- Applicant: Fulwell, LLC
- Decided: Jun 13, 2019 after 175 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 K944602 (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)
- K944602: Valleylab Force FX, Valleylab, Inc. (1995) Summary page 4.

## Indications for use
The Electrosurgical Generator — Model FW-350A is a non-sterile, reusable multi-purpose electrosurgical generator that is designed to perform monopolar and bipolar functions in the surgical operation area.

Source page: https://510kreport.com/device/K183564
Methodology: https://510kreport.com/methodology