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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 553
Failure to Adhere or Bond 360
No code available 83
Other (for use when an appropriate device code cannot be identified) 50
Material frayed 37
Detachment of device or device component 35
Material integrity issue 32
Detachment of device component 30
Bent 26
Needle, separation 25
Device operates differently than expected 20
Battery charger, defective 19
Reaction 16
No Known Device Problem 14
Product quality issue 11
Kinked 10
Device markings issue 10
Split 7
Knotted 7
Unsealed device packaging 7
Crack 6
Dull 6
Sharp/jagged/rough/etched/scratched 5
Material deformation 5
Packaging issue 5
Mechanical issue 5
Coiled 4
Size incorrect for patient 4
Leak 3
No Information 3
Component missing 3
Incomplete or missing packaging 2
Unraveled material 2
Device Issue 2
Tear, rip or hole in device packaging 2
Device misassembled during manufacturing or shipping 2
Device or device fragments location unknown 2
Suture line disruption 2
Unknown (for use when the device problem is not known) 2
Device remains implanted 2
Migration of device or device component 2
Misassembled 2
Device Difficult to Setup or Prepare 1
Material separation 1
Device damaged prior to use 1
Defective component 1
Tip breakage 1
Slippage of device or device component 1
Loose or intermittent connection 1
Device maintenance issue 1
Difficult to insert 1
Burst 1
Difficult to deploy 1
Material disintegration 1
Elective removal 1
Fracture 1
Material fragmentation 1
Loss of or failure to bond 1
Device disinfection or sterilization issue 1
Torn material 1
Material twisted 1
Endarterectomy suture breakage 1
Implant extrusion 1
Solder joint failure 1
Difficult to open or close 1
Dislodged or dislocated 1
Foreign material present in device 1
Human-Device Interface Issue 1
Incorrect device or component shipped 1
Item contaminated during manufacturing or shipping 1
Manufacturing or shipping issue associated with device 1
Total Device Problems 1452

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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