Cool-Tip Rf System

• • Terminated Z-0859-06 FDA Unclassified (pre-2012) ·initiated 21 Apr 2006

  Electrosurgical ablation device may experience loss of power during use, when used with Cool-tip Switching controller in ablation mode.

510(k) Number

K984552 ↗

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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  Class II

  FDA 510(k) K980430 Active Cleared 16 Mar 1998

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  Class II

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  Class II

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• Ocular-Biometer 4000

  Class II

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• Pace-1A Cardiac Stimulator

  Class II

  FDA 510(k) K963579 Active Cleared 8 Nov 1996

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