High Temperature Cautery

• • Terminated Z-1411-04 FDA Unclassified (pre-2012) ·initiated 12 Jul 2004

  The cautery cover cap may become dislodged during shipping or handling, the cautery switch may be activated and the cautery may melt or burn through the packaging pouch.

510(k) Number

K945765 ↗

FDA Product Code

GEI

Device Class

Class II

Regulation

21 CFR Part 878.4400

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Aaron Electrosurgical Handcontrol Pencil, Model ESP5

  Class II

  FDA 510(k) K983761 Active Cleared 30 Dec 1998

• Resistick Solid Laparoscopic Electrodes

  Class II

  FDA 510(k) K971621 Active Cleared 20 Jun 1997

• Neuro Pulse II, III

  Class II

  FDA 510(k) K971143 Active Cleared 6 Jun 1997

• Device, Electrosurgical, Cutting and Coagulation & Accessories

  Class II

  FDA 510(k) K950455 Active Cleared 16 May 1995

• 3RD Hand Helper

  Class II

  FDA 510(k) K911815 Active Cleared 2 Aug 1991

• Aaron 1250 High Frequency Electrosurgical Generator, Model A1250

  Class II

  FDA 510(k) K001955 Active Cleared 22 Dec 2000

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