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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device esophagoscope (flexible or rigid)
Regulation Description Esophagoscope (flexible or rigid) and accessories.
Product CodeEOX
Regulation Number 874.4710
Device Class 2


Premarket Reviews
ManufacturerDecision
BIOSEARCH MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
KARL STORZ GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 6
VISION-SCIENCES, INC.
  SUBSTANTIALLY EQUIVALENT 3
WILSON COOK MEDICAL
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Detachment of device or device component 2
No Known Device Problem 1
Break 1
Material perforation 1
Total Device Problems 5

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 1 0 0 0 1
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Covidien, LLC II Jul-05-2016
2 Pentax Medical Company II Jan-20-2012

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