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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device suture, nonabsorbable, silk
Regulation Description Natural nonabsorbable silk surgical suture.
Product CodeGAP
Regulation Number 878.5030
Device Class 2


Premarket Reviews
ManufacturerDecision
AESCULAP
  SUBSTANTIALLY EQUIVALENT 1
ALCON
  SUBSTANTIALLY EQUIVALENT 1
ARC MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
ARROW INTL., INC.
  SUBSTANTIALLY EQUIVALENT 1
AUROLAB
  SUBSTANTIALLY EQUIVALENT 1
DEMETECH CORP.
  SUBSTANTIALLY EQUIVALENT 1
DRAEGER MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
FOOSIN MEDICAL SUPPLIES INC.
  SUBSTANTIALLY EQUIVALENT 1
INTERNACIONAL FARMACEUTICA, S.A. DE C.V.
  SUBSTANTIALLY EQUIVALENT 1
MANI, INC.
  SUBSTANTIALLY EQUIVALENT 1
SERRAL, S.A. DE C.V.
  SUBSTANTIALLY EQUIVALENT 1
SURGICAL SPECIALTIES CORP.
  SUBSTANTIALLY EQUIVALENT 2
UNITED MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
UNITED STATES SURGICAL
  SUBSTANTIALLY EQUIVALENT 2
  3
VISIONARY MEDICAL SUPPLIES, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Break 41
No code available 16
Unsealed device packaging 11
Reaction 10
Knotted 4
Other (for use when an appropriate device code cannot be identified) 4
Device operates differently than expected 4
Material integrity issue 2
Dull 2
Detachment of device component 2
Migration of device or device component 1
Poor quality image 1
Tip breakage 1
Product quality issue 1
No Known Device Problem 1
Component missing 1
Tear, rip or hole in device packaging 1
Total Device Problems 103

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

Recalls
Manufacturer Recall Class Date Posted
1 Covidien LP II Jul-15-2011
2 Ethicon, Inc. II Jan-09-2015
3 Teleflex Medical II May-07-2014

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