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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device coagulator-cutter, endoscopic, bipolar (and accessories)
Regulation Description Bipolar endoscopic coagulator-cutter and accessories.
Product CodeHIN
Regulation Number 884.4150
Device Class 2


Premarket Reviews
ManufacturerDecision
ELMED
  SUBSTANTIALLY EQUIVALENT 1
ETHICON
  SUBSTANTIALLY EQUIVALENT 1
GYRUS ACMI, INC.
  SUBSTANTIALLY EQUIVALENT 2
KARL STORZ GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 1
MECTRA LABS, INC.
  SUBSTANTIALLY EQUIVALENT 1
RICHARD WOLF
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Break 2
Component(s), overheating of 1
Insulation, hole(s) in 1
Difficult to remove 1
Arcing 1
Total Device Problems 6

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