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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device insufflator, automatic carbon-dioxide for endoscope
Regulation Description Endoscope and accessories.
Product CodeFCX
Regulation Number 876.1500
Device Class 2


Premarket Reviews
ManufacturerDecision
E-Z-EM, INC.
  SUBSTANTIALLY EQUIVALENT 4
FUJI
  SUBSTANTIALLY EQUIVALENT 1
LEXION MEDICAL, LLC.
  SUBSTANTIALLY EQUIVALENT 1
OLYMPUS
  SUBSTANTIALLY EQUIVALENT 1
RICHARD WOLF
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
No Information 2
Accessory incompatible 1
Device alarm system issue 1
Increase in pressure 1
Device inoperable 1
Improper or incorrect procedure or method 1
Suction issue 1
Device operates differently than expected 1
Total Device Problems 9

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

Recalls
Manufacturer Recall Class Date Posted
1 Pentax Medical Company I Oct-28-2013

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