3.5 Mm Side Effect Electrode with Integrated Handpiece, Model 227301, 3.5 Mm Angled Side Effect Electrode with Integrate

• • Terminated Z-0133-2013 FDA Class II ·initiated 12 Mar 2012

  Product may have wrong large product identification label with symbols on the box indicating a S90 VAPR Electrode instead of the VAPR 3.5 hook electrode

• • Terminated Z-2301-2010 FDA Unclassified (pre-2012) ·initiated 7 Jun 2010

  Product does not meet the required packaging specifications for pouch seal integrity which could lead to a breach in sterility

510(k) Number

K082643 ↗

FDA Product Code

GEI

Device Class

Class II

Regulation

21 CFR Part 878.4400

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

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