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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 553
Failure to form staple 189
Other (for use when an appropriate device code cannot be identified) 93
Misfire 62
Tear, rip or hole in device packaging 59
Unsealed device packaging 41
Delivered as unsterile product 33
Loss of or failure to bond 29
Difficult to open or close 26
Premature deployment 20
Deployment issue 19
Mechanical issue 13
Difficult to deploy 13
Break 12
Replace 12
No Known Device Problem 12
Failure to align 9
Loose or intermittent connection 8
Failure to fire 8
Dislodged or dislocated 7
Entrapment of device or device component 7
Failure to deploy 6
Failure to deliver 4
Device operates differently than expected 4
No Information 3
Bent 3
Detachment of device component 2
Failure to cycle 2
Loose 2
Unintended ejection 2
Difficult to remove 2
Device Issue 2
Sticking 2
No code available 2
Environmental Particulates 2
Failure to separate 2
Defective item 2
Clips, scissored 1
Patient-device incompatibility 1
Detachment of device or device component 1
Mechanics altered 1
Packaging issue 1
System fails to activate 1
Twisting 1
Use of Device Issue 1
Noise 1
Unknown (for use when the device problem is not known) 1
Defective component 1
Invalid sensing 1
Slippage of device or device component 1
Malfunction 1
Material erosion 1
Failure to Adhere or Bond 1
Component(s), broken 1
Total Device Problems 1284

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 0 0 0 0 1 0 0 0
Class II 0 0 0 0 0 0 0 0 1 1 1
Class III 0 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
3 Teleflex Medical II May-17-2017
4 Teleflex Medical II Dec-14-2016

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