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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, polyglycolic acid
Regulation Description Absorbable poly(glycolide/l-lactide) surgical suture.
Product CodeGAM
Regulation Number 878.4493
Device Class 2


Premarket Reviews
ManufacturerDecision
AESCULAP
  SUBSTANTIALLY EQUIVALENT 5
ARC MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
AUROLAB
  SUBSTANTIALLY EQUIVALENT 1
COAPT SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 4
DEMETECH CORP.
  SUBSTANTIALLY EQUIVALENT 3
DEPUY INTL., LTD.
  SUBSTANTIALLY EQUIVALENT 3
ETHICON
  1
  SUBSTANTIALLY EQUIVALENT 16
GENZYME CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
INTERNACIONAL FARMACEUTICA, S.A. DE C.V.
  SUBSTANTIALLY EQUIVALENT 3
JOHNSON & JOHNSON
  SUBSTANTIALLY EQUIVALENT 1
MANI, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE
  SUBSTANTIALLY EQUIVALENT 1
MITEK
  SUBSTANTIALLY EQUIVALENT 1
NEAT STITCH LTD.
  SUBSTANTIALLY EQUIVALENT 1
PETERS SURGICAL
  SUBSTANTIALLY EQUIVALENT 1
SAMYANG CORP.
  SUBSTANTIALLY EQUIVALENT 1
SERRAL, S.A. DE C.V.
  SUBSTANTIALLY EQUIVALENT 1
SHANGHAI PUDONG JINHUAN MEDICAL PRODUCTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SURGICAL SPECIALTIES CORP.
  SUBSTANTIALLY EQUIVALENT 7
SUTURES INDIA PVT., LTD.
  SUBSTANTIALLY EQUIVALENT 2
TELEFLEX MEDICAL
  SUBSTANTIALLY EQUIVALENT 3
TYCO HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 3
UNITED MEDICAL
  SUBSTANTIALLY EQUIVALENT 4
UNITED STATES SURGICAL
  4
  SUBSTANTIALLY EQUIVALENT 8
VISIONARY MEDICAL SUPPLIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
VYGON CORP.
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Break 1102
Other (for use when an appropriate device code cannot be identified) 641
Reaction 236
Needle, separation 212
No code available 183
Failure to Adhere or Bond 180
No Known Device Problem 85
Absorption 55
Device operates differently than expected 47
Bent 43
Packaging issue 42
Material integrity issue 29
Detachment of device component 28
Unknown (for use when the device problem is not known) 27
Detachment of device or device component 23
Defective item 20
No Information 15
Material frayed 14
Product quality issue 13
Battery charger, defective 13
Device or device fragments location unknown 11
Device markings issue 11
Material deformation 10
Degraded 10
Failure to unwrap 10
Defective component 7
Knotted 7
Device remains implanted 7
Manufacturing or shipping issue associated with device 7
Device misassembled during manufacturing or shipping 6
Tear, rip or hole in device packaging 6
Material disintegration 6
Patient-device incompatibility 6
Tip breakage 5
Component missing 5
Material fragmentation 5
Implant extrusion 5
Difficult to open or remove packaging material 5
Nonstandard device or device component 4
Incomplete or missing packaging 4
Device packaging compromised 4
Unraveled material 4
Incompatibility problem 3
Migration of device or device component 3
Item contaminated during manufacturing or shipping 3
Material perforation 3
Device damaged prior to use 2
Device Issue 2
Delivered as unsterile product 2
Loss of or failure to bond 2
Delamination 1
Device displays error message 1
Difficult to remove 1
Burst 1
Failure to cycle 1
Folded 1
Mechanical jam 1
Material rigid or stiff 1
Material separation 1
Out-of-box failure 1
Device, removal of (non-implant) 1
Failure to conduct 1
Material erosion 1
Kinked 1
Cut in material 1
Slippage of device or device component 1
Mechanical issue 1
Naturally worn 1
Torn material 1
Total Device Problems 3192

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 2 1 1 2 1 1 1 2 1 0
Class III 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 C P Medical Inc. II Nov-19-2011
3 Coloplast Manufacturing US, LLC II Jun-05-2013
4 Ethicon, Inc. II May-18-2010
5 Ethicon, Inc. II May-12-2009
6 Ethicon, Inc. II Oct-02-2008
7 Mani, Inc. - Kiyohara Facility II Jan-11-2012
8 Silhouette Lift, Inc. II Jul-23-2015
9 Telefelx Medical II Aug-26-2010
10 Teleflex Creek Dr II Jul-17-2007
11 Teleflex Medical II May-07-2014
12 Teleflex Medical II May-01-2014

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