Tissuelink Bipolar Floating Ball Device

• 2 recalls, same reason

  • Terminated Z-1416-04 FDA Unclassified (pre-2012) ·initiated 22 Jul 2004
  • Terminated Z-1415-04 FDA Unclassified (pre-2012) ·initiated 22 Jul 2004

  Adapter when connected to a generator may short circuit resulting in lack of power and/or thermal warming of the ADP housing.

510(k) Number

K022532 ↗

FDA Product Code

GEI

Device Class

Class II

Regulation

21 CFR Part 878.4400

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Tissuelink Aquamantys Malleable Bipolar Sealer with Light

  Class II

  FDA 510(k) K073495 Active Cleared 9 Jan 2008

• Tissuelink Bipolar Forceps

  Class II

  FDA 510(k) K003005 Active Cleared 8 Dec 2000

• Tissuelink Bipolar Floating Ball Device

  Class II

  FDA 510(k) K020574 Active Cleared 20 May 2002

• Modification to Tissuelink Bipolar Forceps

  Class II

  FDA 510(k) K010661 Active Cleared 3 May 2001

• Modification to Tissuelink Monopolar Floating Ball

  Class II

  FDA 510(k) K010662 Active Cleared 27 Apr 2001

• Tissuelink Monopolar Floating Ball'

  Class II

  FDA 510(k) K002680 Active Cleared 13 Nov 2000

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