# K123353: Ciq Controller, Ciq Wands

- Pathway: 510(k) (Traditional)
- Applicant: ArthroCare Corporation
- Decided: Apr 5, 2013 after 156 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: 12 generations back to K936109 (1994). 62 ancestors in all.
No later device cites it as a predicate yet.
0 of 63 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070374: Arthrocare Ent Plasma Wand, Arthrocare Corp. (2007) Summary page 1.
- K063538: Arthrocare Controller (System 2000 and 8000), Arthrocare Patient Cable, Foot Control, Power Cord and Wands, Arthrocare Corp. (2006) Summary page 1.
- K033257: Arthrocare Ent Plasma Wands, Arthrocare Corp. (2003) Summary page 1.
- K014290: Entec Plasma Wands, Arthrocare Corp. (2002) Summary page 1.
- K091674: Arthrocare Coblator IQ System, Arthrocare Corp. (2010) Summary page 1.

## Indications for use
The ArthroCare® Coblator IQ™ ENT System is indicated for ablation, resection, and coagulation of soft tissue and hemostasis of blood vessels in otorhinolaryngology (ENT) surgery including: Adenoidectomy Head, Neck, Oral, and Sinus Surgery Myringotomy with Effective Hemorrhage Control Nasopharyngeal/Laryngeal indications including Tracheal Procedures, Laryngeal Polypectomy, and Laryngeal Lesion Debulking Papilloma Keloids Submucosal Tissue Shrinkage Traditional Uvulopalatoplasty (RAUP) Tissue in the Uvula/Soft Palate for the treatment of Snoring Cysts Mastoidectomy Nasal Airway Obstruction by Reduction of Hypertrophic Nasal Turbinates Neck Mass Submucosal Palatal Shrinkage Tonsillectomy (including palatine tonsils) Tumors

Source page: https://510kreport.com/device/K123353
Methodology: https://510kreport.com/methodology
