Rita Model 1500X Electrosurgical Rf Generator and Accessories (E.G., Rita Thermo Pad and Cable Adapter)

• • Terminated Z-0087-04 FDA Unclassified (pre-2012) ·initiated 6 Oct 2003

  The product displays inaccurate temperature readings, patient skin burns can occur before getting to higher temperature reading.

510(k) Number

K031926 ↗

FDA Product Code

GEI

Models / Variants

1500X Electrosurgical Rf Generator

Accessories (E.G.

Rita Thermo Pad

Cable Adapter)

Device Class

Class II

Regulation

21 CFR Part 878.4400

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Vortex Ez Vascular Access Port

  Class II

  FDA 510(k) K050176 Active Cleared 25 Feb 2005

• Omnipicc Pi

  Class II

  FDA 510(k) K051102 Active Cleared 23 Nov 2005

• Rita Rf Generator and Accessories, Model 500 Series

  Class II

  FDA 510(k) K983214 Active Cleared 27 Mar 2000

• Rita Model 1500X Electrosurgical Rf Generator

  Class II

  FDA 510(k) K031257 Active Cleared 2 May 2003

• Rita System

  Class II

  FDA 510(k) K021329 Active Cleared 9 Oct 2002

• Omnipicc P.I.

  Class II

  FDA 510(k) K062579 Active Cleared 28 Nov 2006

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