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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device unit, cautery, thermal, battery-powered
Regulation Description Thermal cautery unit.
Product CodeHQP
Regulation Number 886.4115
Device Class 2


Premarket Reviews
ManufacturerDecision
AARON MEDICAL
  SUBSTANTIALLY EQUIVALENT 4
KIRWAN SURGICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
MODERN MEDICAL EQUIPMENT MFG., LTD.
  SUBSTANTIALLY EQUIVALENT 1
PMT CORP.
  SUBSTANTIALLY EQUIVALENT 1
STARION INSTRUMENTS
  SUBSTANTIALLY EQUIVALENT 3
XOMED, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Cautery 1
Overheating of device or device component 1
Power Conditioning Issue 1
Dissatisfaction 1
Device disinfection or sterilization issue 1
Device operates differently than expected 1
No Known Device Problem 1
Total Device Problems 7

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 0 0 0 0 0 0
Class III 0 0 0 0 0 0 0 0 0 0


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