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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device evacuator, gastro-urology
Regulation Description Gastroenterology-urology evacuator.
Product CodeKQT
Regulation Number 876.4370
Device Class 2


Premarket Reviews
ManufacturerDecision
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 1
JOHNSON & JOHNSON
  SUBSTANTIALLY EQUIVALENT 1
NORTHGATE TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 2
SAGE PRODUCTS
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Tube(s), splitting of 2
Tubing, incorrect placement of 1
Unknown (for use when the device problem is not known) 1
Break 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 1 0 0 1 0 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Civco Medical Instruments Inc II Aug-28-2014
2 Northgate Technologies, Inc. II Sep-09-2011

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