ARTHROCARE CONTROLLERS - H3000-00

• • Terminated Z-1321-2016 FDA Class II ·initiated 3 Mar 2016

  During functional testing of devices after real time aging, it was determined that product failed to meet shelf-life at the expiration date indicated on the product labels.

510(k) Number

K080282 ↗

FDA Product Code

GEI

Models / Variants

H2076-00

H2079-00

H3000-00

H4000-00;

Device Class

Class II

Regulation

21 CFR Part 878.4400

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

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  Class IIb

  CE/MDR

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  CE/MDR GUDID on market

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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 →