• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search Back To Search Results
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 469
Failure to form staple 179
Other (for use when an appropriate device code cannot be identified) 93
Misfire 55
Unsealed device packaging 41
Delivered as unsterile product 32
Loss of or failure to bond 29
Difficult to open or close 25
Deployment issue 18
Difficult to deploy 13
Mechanical issue 13
Replace 12
Break 11
No Known Device Problem 11
Loose or intermittent connection 8
Dislodged or dislocated 7
Failure to fire 7
Premature deployment 5
Failure to deploy 5
Failure to deliver 4
Device operates differently than expected 4
No Information 3
Failure to align 3
Entrapment of device or device component 3
Bent 3
Difficult to remove 2
Unintended ejection 2
Loose 2
Detachment of device component 2
Failure to cycle 2
Failure to separate 2
Device Issue 2
Sticking 2
No code available 2
Defective item 2
Patient-device incompatibility 1
Environmental Particulates 1
Detachment of device or device component 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
Malfunction 1
Slippage of device or device component 1
Clips, scissored 1
Failure to Adhere or Bond 1
Component(s), broken 1
Material erosion 1
Total Device Problems 1089

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

-
-