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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device system, gastrointestinal motility (electrical)
Regulation Description Gastrointestinal motility monitoring system.
Product CodeFFX
Regulation Number 876.1725
Device Class 2


Premarket Reviews
ManufacturerDecision
BIOSEARCH MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
GIVEN IMAGING
  SUBSTANTIALLY EQUIVALENT 1
LIFE-TECH INT'L., INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 7
MENTOR CORP.
  SUBSTANTIALLY EQUIVALENT 1
WILSON COOK MEDICAL
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Difficult to remove 5
Patient-device incompatibility 4
Device operates differently than expected 3
Entrapment of device or device component 2
Failure to remove enzymatic cleaner 1
Loss of or failure to bond 1
Break 1
Crack 1
Loss of Data 1
Device damaged prior to use 1
Total Device Problems 20

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 0 0 0 0 0 0 0 0
Class II 0 0 0 0 1 1 0 0 0 0 0
Class III 0 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Sandhill Scientific, Inc II May-07-2012
2 Sierra Scientific Instruments Inc II Oct-28-2011

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