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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device suture, absorbable, synthetic
Regulation Description Absorbable surgical gut suture.
Product CodeGAN
Regulation Number 878.4830
Device Class 2


Premarket Reviews
ManufacturerDecision
ETHICON
  SUBSTANTIALLY EQUIVALENT 3
SURGICAL SPECIALTIES CORP.
  SUBSTANTIALLY EQUIVALENT 1
UNITED STATES SURGICAL
  1

Device Problems
Other (for use when an appropriate device code cannot be identified) 136
Break 83
Reaction 54
No code available 37
Needle, separation 26
Tear, rip or hole in device packaging 9
Unknown (for use when the device problem is not known) 8
Implant extrusion 7
Detachment of device component 5
Absorption 3
Bent 2
No Known Device Problem 2
Device Issue 1
Failure to Adhere or Bond 1
Migration of device or device component 1
Total Device Problems 375

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