ArthroCare Controller (System 12000), Patient Cable, Foot Control, Power Cord, Wands

No FDA recalls found in the data synced 22 Oct 2026.

Full name

Arthrocare Controller (System 12000), Arthrocare Patient Cable, Foot Control, Power Cord, Wands

510(k) Number

K082666 ↗

FDA Product Code

GEI

Device Class

Class II

Regulation

21 CFR Part 878.4400

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

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• Arthrocare Arthroscopic Eletrosurgery System (Model 980)

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• EVac 70 Xtra Plasma Wand with Integrated Cable, PROcise XP Plasma Wand with Integrated Cable

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• Modification to Arthrocare Controller, Arthrocare Cable, Footswitch, Powercord, Arthrowands and Spine Wands

  Class II

  FDA 510(k) K000511 Active Cleared 13 Mar 2000

See all devices from ArthroCare Corporation →

• What types of surgical procedures is the ArthroCare Controller (System 12000) primarily designed for?

  The ArthroCare Controller (System 12000) is specifically designed for arthroscopic and orthopedic surgical procedures. It uses bipolar, high-frequency electrosurgery to enable precise cutting and coagulation of tissue during minimally invasive surgeries, such as those involving joints or soft tissue repair.

• Is the ArthroCare Controller system reusable, and how are the Wands supplied?

  The ArthroCare Controller itself, including the Patient Cable, Foot Control, and Power Cord, is a reusable system. However, the Wands are disposable and intended for single-use only, ensuring sterility and safety for each surgical procedure.

• What regulatory pathway was followed for FDA clearance of this device?

  The ArthroCare Controller (System 12000) received FDA clearance through a 510(k) premarket notification process, specifically under product code GEI (General, Plastic Surgery). The clearance was granted as substantially equivalent to a predicate device, with a decision date of October 15, 2008.

• Are there any specific storage requirements mentioned for the reusable components of this system?

  The provided data does not specify any particular storage requirements for the reusable components (Controller, Patient Cable, Foot Control, or Power Cord). However, standard surgical equipment storage guidelines should be followed to maintain functionality and hygiene, such as keeping the device in a clean, dry environment and protecting it from physical damage.

• How is the system powered, and what controls are included for user operation?

  The ArthroCare Controller (System 12000) is powered via the included Power Cord, which connects to an external electrical source. User operation is managed through the Foot Control, allowing the surgeon to activate the bipolar electrosurgical function during procedures without needing to manually engage the device.