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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device endoscopic suture/plication system, gastroesophageal reflux disease (gerd)
Regulation Description Endoscope and accessories.
Definition To treat the symptoms of chronic gastroesophageal reflux disease (GERD), either by approximating tissue with sutures or plicating tissue with an implant.
Product CodeODE
Regulation Number 876.1500
Device Class 2


Premarket Reviews
ManufacturerDecision
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
No Known Device Problem 7
Failure to fire 1
Total Device Problems 8

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 0 2 0 0 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Endogastric Solutions Inc II Aug-17-2013
2 Endogastric Solutions Inc II Apr-17-2013

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