Rita Starburst Xli Electrosurgical Device

• • Terminated Z-0411-2020 FDA Class II ·initiated 2 Oct 2019

  The devices are not labelled correctly. End users impacted by this issue may experience a procedural delay.

• • Terminated Z-0887-06 FDA Unclassified (pre-2012) ·initiated 2 May 2006

  Misbranding; Product may have the wrong device handle which incorrectly identifies the product and also has incorrect deployment depth marker.

• • Terminated Z-0888-06 FDA Unclassified (pre-2012) ·initiated 2 May 2006

  Misbranding; Product may have the wrong device handle which incorrectly identifies the product and also has incorrect deployment depth marker

510(k) Number

K010060 ↗

FDA Product Code

GEI

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

See all devices from Rita Medical Systems, Inc. →