# K230194: HF Surgery Generator 400KHZ

- Pathway: 510(k) (Traditional)
- Applicant: Richard Wolf Medical Instruments Corporation
- Decided: Mar 22, 2023 after 57 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). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K193591: ARC 400, Bowa-Electronics GmbH & Co. KG (2020) Summary page 5.

## Indications for use
The product is used for generating high frequency electrical current for cutting and coagulating tissue electrosurgically.

Source page: https://510kreport.com/device/K230194
Methodology: https://510kreport.com/methodology