# K013463: Arthrocare Arthro Wands, Enetec Evac Plasma Wand

- Pathway: 510(k) (Special)
- Applicant: Arthrocare Corp.
- Decided: Nov 15, 2001 after 28 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: 1 generation back to K011083 (2001). 2 ancestors in all.
134 later devices descend from it; 4 cite it directly.
0 of 137 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011083: Arthrocare System 2000 Controller, Cable, Footswitch, Power Cord & Arthrocare Arthrowand, Arthrocare Corp. (2001) Summary page 1.
- K011279: Entec Evac Plasma Wand, Arthrocare Corp. (2001) Summary page 3.

## Most influential descendants
- K021777: Gyrus Ent Cogent 2/G2 System (Generator,Accessories Somnoplasty Electrodes and Plasmacision Electrodes) (2002), 76 descendants of its own
- K020557: Arthrocare Controller; Arthrocare Cable; Foot Control; Power Cord; Wands (2002), 55 descendants of its own
- K030551: Arthrocare Controller (System 2000 and 8000); Arthrocare Patient Cable; Foot Control; Power Cord; Wands (2003), 52 descendants of its own
- K032504: Arthrocare System (2003), 51 descendants of its own
- K034004: Diego RF Powered Dissector and Drill System Console (2004), 50 descendants of its own

## Indications for use
ArthroCare ArthroWands The ArthroCare ArthroWands are indicated for resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in arthroscopic and orthopedic procedures: Ablation and Debridement ACL/PCL Knee Acromioplasty Shoulder Articular Cartilage All Joints Bursectomy All Joints Chondroplasty All Joints Facia All Joints Ligament All Joints Notchplasty Knee Scar Tissue All Joints Soft Tissue All Joints Subacromial Decompression Shoulder Synovectomy All Joints Tendon All Joints Excision and Resection Acetabular Labrum Hip Articular Labrum All Joints Capsule All Joints Capsular Release Knee Cartilage Flaps Knee Cysts All Joints Discoid Meniscus Knee Frozen Shoulder Release Shoulder Glenoidale Labrum Shoulder Lateral Release Knee Ligament All Joints Loose Bodies All Joints Meniscal Cystectomy Knee Meniscectomy Knee Plica Removal All Joints Scar Tissue All Joints Soft Tissue All Joints Synovial Membrane All Joints Tendon All Joints Triangular Fibrocartilage (TFCC) Wrist Villusectomy Knee Coagulation ACL/PCL Knee Articular Cartilage All Joints Carpal Ligaments Wrist Glenohumeral Capsule Shoulder Ligament All Joints Medial Retinaculum Knee Rotator Cuff Shoulder Tendon All Joints Wrist Tendons Wrist ENTec EVac Plasma Wand The ENTec EVac Plasma Wand is indicated for ablation, coagulation, and hemostasis of soft tissue in tonsillectomy and adenoidectomy procedures.

Source page: https://510kreport.com/device/K013463
Methodology: https://510kreport.com/methodology