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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device brush, endometrial
Regulation Description Endometrial brush.
Product CodeHFE
Regulation Number 884.1100
Device Class 2


Premarket Reviews
ManufacturerDecision
COOK, INC.
  SUBSTANTIALLY EQUIVALENT 3
  1.  K082066  TAO BRUSH I.U.M.C. ENDOMETRIAL SAMPLER
  2.  K911620  STOVALL ENDOMETRIAL BRUSH
  3.  K941298  IUMC ENDOMETRIAL SAMPLER

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 1 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 Cook OB/Gyn, Inc. II Jun-16-2009

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