# K063538: Arthrocare Controller (System 2000 and 8000), Arthrocare Patient Cable, Foot Control, Power Cord and Wands

- Pathway: 510(k) (Special)
- Applicant: Arthrocare Corp.
- Decided: Dec 1, 2006 after 7 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). 55 ancestors in all.
40 later devices descend from it; 3 cite it directly.
0 of 96 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033257: Arthrocare Ent Plasma Wands, Arthrocare Corp. (2003) Summary page 1.

## Most influential descendants
- K070374: Arthrocare Ent Plasma Wand (2007), 39 descendants of its own
- K100597: Harmonic Focus Shears (2010), 18 descendants of its own
- K133314: Harmonic Focus Shears + Adaptive Tissue Technology (2013), 9 descendants of its own
- K083415: Peak Plasmablade Tna Tonsil and Adenoid Tissue Dissection Device (2009), 8 descendants of its own
- K151743: THUNDERBEAT Open Fine Jaw (2016), 6 descendants of its own

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

Source page: https://510kreport.com/device/K063538
Methodology: https://510kreport.com/methodology