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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device tissue adhesive for the topical approximation of skin
Regulation Description Tissue adhesive.
Definition Docket number: 2006p-0071 - may 5, 2008 - reclassified from class 3 pma to class 2 510(k).
Product CodeMPN
Regulation Number 878.4010
Device Class 2


Premarket Reviews
ManufacturerDecision
ADHEZION BIOMEDICAL
  SUBSTANTIALLY EQUIVALENT 1
AESCULAP
  SUBSTANTIALLY EQUIVALENT 3
CHEMENCE MEDICAL PRODUCTS INC.
  SUBSTANTIALLY EQUIVALENT 2
ETHICON
  SUBSTANTIALLY EQUIVALENT 2
GLUSTITCH, INC.
  SUBSTANTIALLY EQUIVALENT 1
KIMBERLY-CLARK CORP.
  SUBSTANTIALLY EQUIVALENT 3

Premarket Approvals (PMA)
2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
1 0 0 0 0 0 0 0 0 0

Device Problems
Reaction 80
Other (for use when an appropriate device code cannot be identified) 78
No code available 73
No Known Device Problem 29
No Information 7
Component missing 6
Device operates differently than expected 6
Chemical issue 3
Unknown (for use when the device problem is not known) 3
Failure to Adhere or Bond 3
Incomplete or missing packaging 2
Defective item 2
Material integrity issue 1
Packaging issue 1
Break 1
Burn of device or device component 1
Detachment of device component 1
Fluid leak 1
Hole in material 1
Unsealed device packaging 1
Material perforation 1
Total Device Problems 301

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 0 0 0 0
Class III 0 0 0 0 0 0 0 0 0 0


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