# K191064: Argon Handset

- Pathway: 510(k) (Traditional)
- Applicant: New Deantronics Taiwan, Ltd.
- Decided: Jun 12, 2019 after 51 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 K964636 (1997). 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)
- K964636: Force Argon II Argon Enhanced Electrosurgical System, Valleylab, Inc. (1997) Summary page 4.

## Indications for use
The Argon Handset is an electrosurgical accessory intended to be used in open or laparoscopic and thoracoscopic surgical procedures (general, neurosurgical, gynecologic) where monopolar standard or argon-enhanced electrosurgery is desired. The electrosurgical energy is controlled by the electrosurgical generator during cutting and coagulation and the argon gas flow is controlled by the argon gas delivery system, via the Argon Handset, during argon-shrouded cutting and argon-enhanced coagulation. When the Argon Handset is activated in the argon-enhanced mode, argon gas plasma is created between the electrode and target tissue.

Source page: https://510kreport.com/device/K191064
Methodology: https://510kreport.com/methodology