# K200169: VFS1 Bipolar Electrosurgical Generator

- Pathway: 510(k) (Traditional)
- Applicant: FHC, Inc.
- Decided: May 14, 2020 after 112 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 K854413 (1985). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050364: Malis 2000 Bipolar Electrosurgical System, Valley Forge Scientific Corp. (2005) Summary page 4.
- K033499: Malis Irrigation Module 1000, Valley Forge Scientific Corp. (2003) Summary page 4.

## Indications for use
The VFS l Bipolar Electrosurgical Generator is indicated for use in micro, macro, and endoscopic bipolar irrigation, cutting and coagulating of tissue and the coagulation of blood vessels in all types of surgery.

Source page: https://510kreport.com/device/K200169
Methodology: https://510kreport.com/methodology