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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device low energy direct current thermal ablation system
Regulation Description Electrosurgical cutting and coagulation device and accessories.
Definition Ablation of soft tissue
Product CodeOAB
Regulation Number 878.4400
Device Class 2


Premarket Reviews
ManufacturerDecision
ANGIODYNAMICS, INC.
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
No Information 4
No Known Device Problem 3
Material separation 1
Device stops intermittently 1
Failure to auto stop 1
Total Device Problems 10

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 0 0 0 0 0
Class II 0 0 0 0 1 1 0 0 0 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Angiodynamics Worldwide Headquarters II Jan-27-2012
2 Angiodynamics, Inc. II Sep-23-2011

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