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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, polyamide
Regulation Description Nonabsorbable polyamide surgical suture.
Product CodeGAR
Regulation Number 878.5020
Device Class 2


Premarket Reviews
ManufacturerDecision
AESCULAP
  SUBSTANTIALLY EQUIVALENT 3
ALCON
  SUBSTANTIALLY EQUIVALENT 1
ARC MEDICAL
  1
ARTIMPLANT AB
  SUBSTANTIALLY EQUIVALENT 2
AUROLAB
  SUBSTANTIALLY EQUIVALENT 1
DEMETECH CORP.
  SUBSTANTIALLY EQUIVALENT 1
FSSB CHIRURGISCHE NADELN GMBH
  SUBSTANTIALLY EQUIVALENT 1
GENZYME CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
INTERNACIONAL FARMACEUTICA, S.A. DE C.V.
  SUBSTANTIALLY EQUIVALENT 1
MANI, INC.
  SUBSTANTIALLY EQUIVALENT 1
QUILL MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
S. JACKSON, INC.
  SUBSTANTIALLY EQUIVALENT 4
SERRAL, S.A. DE C.V.
  SUBSTANTIALLY EQUIVALENT 1
SURGICAL SPECIALTIES CORP.
  SUBSTANTIALLY EQUIVALENT 1
UNILENE S.A.C.
  SUBSTANTIALLY EQUIVALENT 1
UNITED MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
UNITED STATES SURGICAL
  1
  SUBSTANTIALLY EQUIVALENT 2
VISIONARY MEDICAL SUPPLIES, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Break 109
Failure to Adhere or Bond 28
Other (for use when an appropriate device code cannot be identified) 23
Bent 12
Detachment of device component 10
No code available 10
Reaction 7
Needle, separation 4
Unknown (for use when the device problem is not known) 4
Device markings issue 4
Device operates differently than expected 4
Detachment of device or device component 3
Stretched 3
Tear, rip or hole in device packaging 3
Nonstandard device or device component 3
Knotted 3
Product quality issue 3
Material frayed 3
Battery charger, defective 2
Unsealed device packaging 2
Dull 2
Defective component 2
Size incorrect for patient 2
Manufacturing or shipping issue associated with device 2
No Known Device Problem 2
Packaging issue 2
Item contaminated during manufacturing or shipping 1
Device misassembled during manufacturing or shipping 1
Component missing 1
Incomplete or missing packaging 1
Split 1
Implant extrusion 1
Device damaged prior to use 1
Material rupture 1
Misassembled 1
Delivered as unsterile product 1
Loss of or failure to bond 1
Kinked 1
Total Device Problems 264

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 0 0 0 0 0
Class II 0 0 0 0 1 0 0 2 0 0
Class III 0 1 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Aesculap, Inc. II Jul-09-2014
2 C P Medical Inc. II Sep-09-2011
3 Surgical Specialties Corp III Oct-02-2008
4 Teleflex Medical II May-07-2014

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