Arthrocare Cavity Spinewand

• • Terminated Z-0623-2016 FDA Class II ·initiated 26 Oct 2015

  There is cracking in the tray when the device is snapped into place. The crack is through the full thickness of the tray, compromising the sterile barrier.

510(k) Number

K063172 ↗

FDA Product Code

GEI

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

• Arthro Class IIb ARTC-TF-038 FLOW FLEXTEND COBLATION Wand

  Class IIb

  CE/MDR GUDID on market

• FLOW FLEXTEND Wand (72290039)

  Class II

  FDA 510(k) K254122 Active Cleared 30 Mar 2026

• 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 →