# K011634: Arthrocare Controller, Model H2000; Arthrocare Cable, Model H0970-02; Footswitch, Model H2000-04; Powercord, Model H2000

- Pathway: 510(k) (Special)
- Applicant: Arthrocare Corp.
- Decided: Jun 19, 2001 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: 1 generation back to K000778 (2000). 5 ancestors in all.
41 later devices descend from it; 2 cite it directly.
0 of 47 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000778: Entec Reflex Wand 55, Model E4055-01, E4045-01, Arthrocare Corp. (2000) Summary page 1.
- K001588: Arthrocare System 2000 Controller, Arthrocare System 2000 Cable, Arthrocare System 2000 Footswitch, Arthrocare System 20, Arthrocare Corp. (2000) Summary page 3.
- K001936: Arthrocare Controller, Arthrocare Cable, Footswitch, Powercord, Arthrocare Corp. (2000) Summary page 1.
- K003624: Refinity System, Refinity Handpiece and Cable, Refinity Footswitch, Refinity Power Cord, Model V5100-00,V5701-00,V5702, Arthrocare Corp. (2000) Summary page 1.
- K010568: Arthrocare Urology Electrosurgery System, Arthrocare Corp. (2001) Summary page 1.

## Most influential descendants
- K020832: Arthrocare Controller, Arthrocare Cable, Foot Control, Power Cord, Wands (2002), 40 descendants of its own
- K040338: Arthrocare Controller, Cable, Foot Control, Power Cord, Wands, Models H0970-02, H2000-04, H2000-05, H0970-06 (2004), 24 descendants of its own
- K071963: Modification to: Arthrocare Arthrowands (2007), 21 descendants of its own
- K072865: Modificaton to: Arthrocare Arthrowands (2007), 20 descendants of its own
- K082323: Arthrocare Arthrowands (2008), 19 descendants of its own

## Indications for use
The ENTec ReFlex Wand is indicated for ablation and coagulation of soft tissue in otolaryngological (ENT) procedures, including the treatment of snoring, nasal airway obstruction by reduction of hypertrophic nasal turbinates, and submucosal tissue shrinkage. The ArthroCare System 2000 is indicated for resection, ablation, and coagulation of soft tissues and hemostasis of blood vessels in orthopedic, arthroscopic, spinal, and neurosurgical procedures. The ENTec Surgery System is intended for ablation and coagulation of soft tissue in otorhinolaryngology (ENT) surgery including head, neck, oral, and sinus surgery. The ArthroCare Orthopedic Electrosurgery System is indicated for resection, ablation, and coagulation of soft tissues and hemostasis of blood vessels in orthopedic, arthroscopic, and spinal procedures. The ArthroCare Electrosurgery System is indicated for resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in general, plastic, and reconstructive surgery. It is intended to be used in procedures using conductive solutions, such as normal saline. The Visage Cosmetic Surgery System is a bipolar electrosurgical device intended for general dermatologic surgery that may include skin resurfacing for the treatment of wrinkles, rhytids, and furrows, as well as soft tissue resection/removal and hemostasis/coagulation. It is intended to be used in procedures using conductive solutions such as normal saline. The ArthroCare Bipolar Loop is indicated for resection, ablation, and excision, as well as hemostasis of blood vessels in patients requiring endoscopic surgery for general urological procedures including transurethral prostatectomy (TURP), transurethral incisions in the prostate (TUIP), and non-malignant tumors of the bladder wall.

Source page: https://510kreport.com/device/K011634
Methodology: https://510kreport.com/methodology