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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device system, imaging, gastrointestinal, wireless, capsule
Regulation Description Ingestible telemetric gastrointestinal capsule imaging system.
Product CodeNEZ
Regulation Number 876.1300
Device Class 2


Premarket Reviews
ManufacturerDecision
GIVEN IMAGING
  GRANTED 1
  SUBSTANTIALLY EQUIVALENT 16
OLYMPUS
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
No Known Device Problem 19
Positioning Issue 10
No code available 7
Entrapment of device or device component 6
Patient-device incompatibility 5
Failure to advance 4
Device operates differently than expected 3
No Information 3
Communication or transmission issue 2
Difficult to remove 2
Incorrect or inadequate result 2
Material disintegration 2
No display or display failure 1
Break 1
Detachment of device component 1
Difficult to flush 1
Migration of device or device component 1
No device output 1
Use of Device Issue 1
Spark 1
Malposition of device 1
Connection issue 1
Difficult to advance 1
Mechanical jam 1
Output issue 1
Total Device Problems 78

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

Recalls
Manufacturer Recall Class Date Posted
1 Given Imaging Inc II Aug-20-2008
2 Given Imaging Ltd. II Mar-23-2011

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