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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device staple, removable (skin)
Regulation Description Removable skin staple.
Product CodeGDT
Regulation Number 878.4760
Device Class 1


Premarket Reviews
ManufacturerDecision
3M COMPANY
  SUBSTANTIALLY EQUIVALENT 1
BUSSE HOSPITAL DISPOSABLES, INC.
  SUBSTANTIALLY EQUIVALENT 1
CONTINENTAL MEDICAL LABORATORIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
DEROYAL
  SUBSTANTIALLY EQUIVALENT 1
ETHICON
  SUBSTANTIALLY EQUIVALENT 2
PILLING WECK
  SUBSTANTIALLY EQUIVALENT 1
UNITED STATES SURGICAL
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Mechanical jam 107
Failure to form staple 100
Other (for use when an appropriate device code cannot be identified) 93
Misfire 34
Loss of or failure to bond 29
Delivered as unsterile product 29
Deployment issue 16
Difficult to open or close 15
Replace 12
Mechanical issue 11
Difficult to deploy 10
No Known Device Problem 9
Dislodged or dislocated 7
Unsealed device packaging 7
Break 5
Premature deployment 4
Failure to deliver 4
Device operates differently than expected 4
Bent 3
Failure to deploy 2
Detachment of device component 2
Loose 2
Difficult to remove 2
Sticking 2
Device Issue 2
Failure to align 2
Failure to separate 2
Defective item 2
Failure to fire 2
No code available 2
No Information 1
Detachment of device or device component 1
Patient-device incompatibility 1
Clips, scissored 1
Malfunction 1
Slippage of device or device component 1
Unknown (for use when the device problem is not known) 1
Defective component 1
Invalid sensing 1
System fails to activate 1
Twisting 1
Use of Device Issue 1
Noise 1
Material erosion 1
Failure to Adhere or Bond 1
Component(s), broken 1
Total Device Problems 537

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 0 0 1 0 0
Class II 0 0 0 0 0 0 0 0 1 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Customed, Inc II Sep-03-2015
2 Customed, Inc I Dec-16-2014

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