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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device clamp, surgical, general & plastic surgery
Regulation Description Manual surgical instrument for general use.
Product CodeGDJ
Regulation Number 878.4800
Device Class 1


Premarket Reviews
ManufacturerDecision
CORDIS CORP.
  SUBSTANTIALLY EQUIVALENT 1
ETHICON
  SUBSTANTIALLY EQUIVALENT 1
MAR-MED CO.
  SUBSTANTIALLY EQUIVALENT 1
SOLOS ENDOSCOPY, INC
  SUBSTANTIALLY EQUIVALENT 1
UNITED STATES SURGICAL
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Detachment of device component 2
Pierce 1
Tears, rips, holes in device, device material 1
Failure to form staple 1
Positioning Issue 1
Total Device Problems 6

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

Recalls
Manufacturer Recall Class Date Posted
1 Stryker Howmedica Osteonics Corp. II Aug-29-2013

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