# K033257: Arthrocare Ent Plasma Wands

- Pathway: 510(k) (Special)
- Applicant: Arthrocare Corp.
- Decided: Oct 30, 2003 after 21 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: 9 generations back to K936109 (1994). 54 ancestors in all.
42 later devices descend from it; 3 cite it directly.
0 of 97 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030108: Arthrocare Ent Coblator Surgery System, Arthrocare Corp. (2003)

## Most influential descendants
- K063538: Arthrocare Controller (System 2000 and 8000), Arthrocare Patient Cable, Foot Control, Power Cord and Wands (2006), 40 descendants of its own
- 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

## 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 NasopharyngeaVLaryngeal indications including Tracheal Procedures, Laryngeal Polypectomy, and Laryngeal Lesion Debulking Neck Mass Papilloma Keloids Submucosal Palatal Shrinkage Submucosal Tissue Shrinkage Tonsillectomy Traditional Uvulopalatoplasty (RAW) Tumors Tissue in the UvuldSoft Palate for the Treatment of Snoring

Source page: https://510kreport.com/device/K033257
Methodology: https://510kreport.com/methodology