# K070374: Arthrocare Ent Plasma Wand

- Pathway: 510(k) (Traditional)
- Applicant: Arthrocare Corp.
- Decided: Apr 25, 2007 after 76 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K936109 (1994). 56 ancestors in all.
39 later devices descend from it; 9 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)
- K014290: Entec Plasma Wands, Arthrocare Corp. (2002) 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.

## Most influential descendants
- 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
- K192103: Thunderbeat Open Fine Jaw Type X Hand Instrument (2020), 4 descendants of its own

## Recalls of this device
- Jun 2, 2015 · Class II · Z-2105-2015: Wands inspected with the adaptor fixture were released to the field not meeting the dielectric (Hipot) specifications.

## Indications for use
The ArthroCare ENT Plasma Wands is for ablation, resection, and coagulation of soft tissue and hemostasis of blood vessels in otorbinolaryngology (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 (including palatine tonsils) Traditional Uvulopalatoplasty (RAUP) Tumors Tissue in the Uvula/Soft Palate for the Treatment of Snoring

Source page: https://510kreport.com/device/K070374
Methodology: https://510kreport.com/methodology