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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 2017
1 0 0 0 0 0 0 0 0 0 0

Device Problems
No code available 110
Reaction 80
Other (for use when an appropriate device code cannot be identified) 78
Blockage within device or device component 35
No Known Device Problem 32
Break 27
Failure to Adhere or Bond 12
Insufficient cooling 8
No Information 8
Device operates differently than expected 8
Product quality issue 7
No flow 7
Component missing 7
Leak 4
Unknown (for use when the device problem is not known) 3
Clumping in device or device ingredient 3
Defective item 3
Chemical issue 3
Packaging issue 3
Incomplete or missing packaging 2
Device clogged 2
Unsealed device packaging 2
Fluid leak 2
Hole in material 1
Material perforation 1
Burn of device or device component 1
Detachment of device component 1
Material discolored 1
Device markings issue 1
Improper flow or infusion 1
Material integrity issue 1
Total Device Problems 454

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


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