# K014290: Entec Plasma Wands

- Pathway: 510(k) (Traditional)
- Applicant: Arthrocare Corp.
- Decided: Mar 28, 2002 after 90 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: 6 generations back to K936109 (1994). 51 ancestors in all.
119 later devices descend from it; 7 cite it directly.
0 of 171 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K973478: Arthrocare Sinus Electrosurgery System, Arthrocare Corp. (1998) Summary page 1.
- K000036: Entec Reflex Wand 55, Model E4055-00, Arthrocare Corp. (2000) Summary page 1.
- K000778: Entec Reflex Wand 55, Model E4055-01, E4045-01, Arthrocare Corp. (2000) Summary page 1.
- K011279: Entec Evac Plasma Wand, Arthrocare Corp. (2001) Summary page 1.
- K982717: Somnoplasty System, Models S2, 1010/2010,2000/1000,1100,3000/30XX/6000, 1200, Somnus Medical Technologies, Inc. (1998) Summary page 1.
- K981361: Powerstar Bipolar Scissors, ETHICON, Inc. (1998) Summary page 1.
- K001253: Surgitron Iec II, Ellman Intl., Inc. (2000) Summary page 1.
- K011703: Lumenis Versapulse Powersuite Holmium (HO:Yag) and Dual Wavelength (HO:Yag/ND:Yag) Surgical Lasers and Delivery Devices, Lumenis (2001) Summary page 1.
- K002987: Redtronic Xomed Monopolar Energized Blade, Xomed, Inc. (2000) Summary page 1.

## Most influential descendants
- K021364: Modification to Entec Plasma Wands (2002), 94 descendants of its own
- K030108: Arthrocare Ent Coblator Surgery System (2003), 92 descendants of its own
- K021777: Gyrus Ent Cogent 2/G2 System (Generator,Accessories Somnoplasty Electrodes and Plasmacision Electrodes) (2002), 76 descendants of its own
- K034004: Diego RF Powered Dissector and Drill System Console (2004), 50 descendants of its own
- K072302: Entellus Medical RS-Series System (2008), 44 descendants of its own

## Indications for use
The ENTec 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/K014290
Methodology: https://510kreport.com/methodology