Rita Model 90 Electrosurgical Accessory, Model 90

• • Terminated Z-1143-2015 FDA Class II ·initiated 19 Dec 2014

  Printed mark on the trocar intended to indicate a 5cm distance from the distal tip of the needle is actually located 4cm from the distal tip of the needle.

• 2 recalls, same reason

  • Terminated Z-0754-2007 FDA Unclassified (pre-2012) ·initiated 3 Apr 2007
  • Terminated Z-0752-2007 FDA Unclassified (pre-2012) ·initiated 3 Apr 2007

  The product may have a cracked tray which can compromise the sterility of the product.

510(k) Number

K992693 ↗

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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