# K193591: ARC 400

- Pathway: 510(k) (Traditional)
- Applicant: Bowa-Electronics GmbH & Co. KG
- Decided: Apr 2, 2020 after 101 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: 4 generations back to K933002 (1994). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171717: Autocon Iii 400, KARL STORZ Endoscopy-America, Inc. (2017) Summary page 4.

## Most influential descendants
- K230194: HF Surgery Generator 400KHZ (2023), 0 descendants of its own

## Indications for use
The High Frequency (HF) device is intended exclusively for the generation of electrical power for monopolar and bipolar cutting and coagulation of tissue structures in surgical operations.

Source page: https://510kreport.com/device/K193591
Methodology: https://510kreport.com/methodology