Athrocare Topaz Arthrowands

• • Terminated Z-1657-2008 FDA Unclassified (pre-2012) ·initiated 31 Jan 2008

  Devices for which sterility may be compromised as evidenced by punctures in the plastic tray during shipping. The risk to the patient is a potential infection subsequent to the surgical procedure.

510(k) Number

K053567 ↗

FDA Product Code

HRX

Device Class

Class II

Regulation

21 CFR Part 888.1100

Advisory Committee

Orthopedic

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 →