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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search Show TPLC since Back To Search Results
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 COMPANY
  SUBSTANTIALLY EQUIVALENT 1
ANGIODYNAMICS, INC.
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Adverse Event Without Identified Device or Use Problem 10
Device Stops Intermittently 4
Communication or Transmission Problem 4
Insufficient Information 4
Failure of Device to Self-Test 3
Material Separation 1
Device Operational Issue 1
Device Remains Activated 1
No Display / Image 1
Failure to Auto Stop 1
Total Device Problems 30


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