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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
No code available 95
Reaction 80
Other (for use when an appropriate device code cannot be identified) 78
No Known Device Problem 30
Blockage within device or device component 24
Break 18
Failure to Adhere or Bond 12
Device operates differently than expected 8
No flow 7
No Information 7
Component missing 7
Product quality issue 6
Packaging issue 3
Defective item 3
Chemical issue 3
Unknown (for use when the device problem is not known) 3
Clumping in device or device ingredient 3
Fluid leak 2
Device clogged 2
Incomplete or missing packaging 2
Leak 2
Unsealed device packaging 2
Material perforation 1
Burn of device or device component 1
Hole in material 1
Detachment of device component 1
Material discolored 1
Improper flow or infusion 1
Material integrity issue 1
Total Device Problems 404

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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