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

• • Terminated Z-2105-2015 FDA Class II ·initiated 2 Jun 2015

  Wands inspected with the adaptor fixture were released to the field not meeting the dielectric (Hipot) specifications.

• • Terminated Z-1832-2015 FDA Class II ·initiated 15 May 2015

  Potential component failure causing device inoperability

• • Terminated Z-1833-2015 FDA Class II ·initiated 15 May 2015

  Potential component failure resulting in inoperability

510(k) Number

K142999 ↗

FDA Product Code

GEI

Regulation

21 CFR Part 878.4400

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

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See all devices from ArthroCare Corporation →