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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device suture, nonabsorbable, synthetic, polypropylene
Regulation Description Nonabsorbable polypropylene surgical suture.
Product CodeGAW
Regulation Number 878.5010
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT
  SUBSTANTIALLY EQUIVALENT 2
AESCULAP
  SUBSTANTIALLY EQUIVALENT 2
AMERICAN MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
ANGIOTECH
  SUBSTANTIALLY EQUIVALENT 2
ARC MEDICAL
  1
AXYA MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 5
COLOPLAST MANUFACTURING US LLC
  SUBSTANTIALLY EQUIVALENT 1
DEMETECH CORP.
  SUBSTANTIALLY EQUIVALENT 1
EDWARDS LIFESCIENCES
  SUBSTANTIALLY EQUIVALENT 1
ETHICON
  SUBSTANTIALLY EQUIVALENT 3
INTERNACIONAL FARMACEUTICA, S.A. DE C.V.
  SUBSTANTIALLY EQUIVALENT 1
KOLSTER METHODS, INC.
  SUBSTANTIALLY EQUIVALENT 2
LSI SOLUTIONS
  SUBSTANTIALLY EQUIVALENT 1
NEOTRACT, INC.
  SUBSTANTIALLY EQUIVALENT 1
PETERS SURGICAL
  SUBSTANTIALLY EQUIVALENT 1
PHILIPS MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
QUILL MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
S. JACKSON, INC.
  SUBSTANTIALLY EQUIVALENT 2
SERRAL, S.A. DE C.V.
  SUBSTANTIALLY EQUIVALENT 1
SURGICAL SPECIALTIES CORP.
  SUBSTANTIALLY EQUIVALENT 5
SUTURA, INC.
  SUBSTANTIALLY EQUIVALENT 4
TYCO HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 1
UNITED MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
UNITED STATES SURGICAL
  SUBSTANTIALLY EQUIVALENT 1
  2
VISIONARY MEDICAL SUPPLIES, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Break 635
Failure to Adhere or Bond 369
No code available 96
Detachment of device or device component 68
Other (for use when an appropriate device code cannot be identified) 50
Material frayed 41
Detachment of device component 36
Material integrity issue 33
Bent 27
Needle, separation 25
Device operates differently than expected 20
Battery charger, defective 19
Reaction 16
No Known Device Problem 15
Split 13
Device markings issue 12
Product quality issue 12
Unsealed device packaging 10
Kinked 10
Knotted 10
Dull 8
Tear, rip or hole in device packaging 6
Crack 6
Mechanical issue 5
Migration of device or device component 5
Packaging issue 5
Material deformation 5
Sharp/jagged/rough/etched/scratched 5
Component missing 4
Coiled 4
Size incorrect for patient 4
Leak 3
Unraveled material 3
No Information 3
Incorrect device or component shipped 3
Device misassembled during manufacturing or shipping 2
Manufacturing or shipping issue associated with device 2
Incomplete or missing packaging 2
Unknown (for use when the device problem is not known) 2
Device Issue 2
Device or device fragments location unknown 2
Loose or intermittent connection 2
Difficult to deploy 2
Suture line disruption 2
Device remains implanted 2
Misassembled 2
Difficult to insert 1
Device Difficult to Setup or Prepare 1
Difficult to remove 1
Material rupture 1
Material separation 1
Tip breakage 1
Slippage of device or device component 1
Material disintegration 1
Elective removal 1
Fracture 1
Material fragmentation 1
Device maintenance issue 1
Loss of or failure to bond 1
Component incompatible 1
Burst 1
Device disinfection or sterilization issue 1
Endarterectomy suture breakage 1
Device damaged prior to use 1
Defective component 1
Solder joint failure 1
Implant extrusion 1
Material Protrusion 1
Material twisted 1
Torn material 1
Item contaminated during manufacturing or shipping 1
Difficult to open or close 1
Difficult to open or remove packaging material 1
Dislodged or dislocated 1
Foreign material present in device 1
Human-Device Interface Issue 1
Total Device Problems 1638

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 1 0 0 0 0 0 0 0 0 1 0
Class III 0 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 C P Medical II May-24-2007
2 SSC- Surgical Specialties Corporation II Jun-21-2016

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