ARTHROCARE CONTROLLER - Arthrocare Controller (System 2000 And 8000)

• • Terminated Z-1900-2009 FDA Unclassified (pre-2012) ·initiated 5 Aug 2008

  Potential Sterility Loss-- Due to wearing or puncture in the Tyvek lid, the product may lose sterility.

510(k) Number

K030551 ↗

FDA Product Code

GEI

Models / Variants

Arthrocare Controller (System 2000 And 8000)

Arthrocare Patient Cable

Foot Control

Power Cord

Wands

Device Class

Class II

Regulation

21 CFR Part 878.4400

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• ARTHRO Class IIb ARTC-TF-037 Intellio Shift Non-Network Enabled Controller and Foot Pedal

  Class IIb

  CE/MDR

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  Class IIb

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  Class II

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• Arthrocare Arthroscopic Eletrosurgery System (Model 980)

  Class II

  FDA 510(k) K963123 Active Cleared 8 Oct 1996

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

  Class II

  FDA 510(k) K142999 Active Cleared 19 Nov 2014

• 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 →