# K131205: Arthrocare Head and Neck Coblation Wand

- Pathway: 510(k) (Traditional)
- Applicant: ArthroCare Corporation
- Decided: Aug 9, 2013 after 102 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: 10 generations back to K936109 (1994). 66 ancestors in all.
No later device cites it as a predicate yet.
0 of 67 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080844: G3 Generator and Accessories-Dissector Plasma Knife, Gyrus Acmi, Inc. (2009) Summary page 1.

## Indications for use
The Head and Neck Coblation Wand is indicated for ablation, resection, and coagulation of soft tissue and hemostasis of blood vessels in otorhinolaryngology (ENT) surgery including: * Cysts * Tumors * Head, neck, and oral surgery * Neck mass The ArthroCare Head and Neck Wand is designed to be used only with the ArthroCare ENT Coblator 11 (CII) Surgery System Controller and ArthroCare Flow Control Unit.

Source page: https://510kreport.com/device/K131205
Methodology: https://510kreport.com/methodology