# K183126: Electrosurgical accessory

- Pathway: 510(k) (Traditional)
- Applicant: New Deantronics Taiwan, Ltd.
- Decided: May 8, 2019 after 176 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 Flexible Argon Electrode is intended to be used in open or laparoscopic and thoracoscopic surgical procedures (general, neurosurgical, gynecologic) where argon-enhanced monopolar coagulation is desired. The Retractable Argon Electrode is intended to be used in laparoscopic and thoracoscopic surgical procedures (general, neurosurgical, gynecologic) where standard monopolar electrosurgery (cutting and coagulation) or argon-enhanced monopolar coagulation is desired. The New Deantronics Argon Electrodes have to be attached to the argon handset and are the electrosurgical electrodes applied in electrosurgical procedures.

Source page: https://510kreport.com/device/K183126
Methodology: https://510kreport.com/methodology