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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 17
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 1356
Other (for use when an appropriate device code cannot be identified) 641
No code available 479
Failure to Adhere or Bond 293
Reaction 237
Needle, separation 212
No Known Device Problem 129
Bent 89
Device operates differently than expected 71
Detachment of device component 63
Migration of device or device component 63
Absorption 55
Packaging issue 51
Detachment of device or device component 39
Product quality issue 35
Material integrity issue 31
Unknown (for use when the device problem is not known) 27
Tear, rip or hole in device packaging 24
Defective item 21
Device markings issue 18
Device or device fragments location unknown 15
Degraded 15
No Information 15
Material frayed 14
Component missing 14
Battery charger, defective 13
Material disintegration 11
Knotted 11
Material fragmentation 10
Unraveled material 10
Device misassembled during manufacturing or shipping 10
Failure to unwrap 10
Material deformation 10
Manufacturing or shipping issue associated with device 8
Incomplete or missing packaging 8
Device remains implanted 7
Defective component 7
Slippage of device or device component 6
Patient-device incompatibility 6
Difficult to open or remove packaging material 5
Implant extrusion 5
Tip breakage 5
Expulsion 4
Device packaging compromised 4
Unsealed device packaging 4
Nonstandard device or device component 4
Component falling 4
Material perforation 3
Item contaminated during manufacturing or shipping 3
Incompatibility problem 3
Torn material 2
Device damaged prior to use 2
Device Issue 2
Out-of-box failure 2
Loss of or failure to bond 2
Entrapment of device or device component 2
Delivered as unsterile product 2
Sticking 2
Unexpected therapeutic results 2
Material rigid or stiff 2
Rejection 2
Difficult to remove 1
Material separation 1
Leak 1
Mechanical issue 1
Kinked 1
Material erosion 1
Unintended ejection 1
Fracture 1
Burst 1
Failure to conduct 1
Crack 1
Failure to cycle 1
Dull 1
Cut in material 1
Split 1
Foreign material present in device 1
Delamination 1
Device disinfection or sterilization issue 1
Device displays error message 1
Device, removal of (non-implant) 1
Folded 1
Incorrect device or component shipped 1
Mechanical jam 1
Naturally worn 1
Total Device Problems 4224

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 2 1 1 2 1 1 1 2 1 1 0
Class III 0 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Aesculap Implant Systems LLC II Oct-26-2016
2 C P Medical II May-24-2007
3 C P Medical Inc. II Nov-19-2011
4 Coloplast Manufacturing US, LLC II Jun-05-2013
5 Ethicon, Inc. II May-18-2010
6 Ethicon, Inc. II May-12-2009
7 Ethicon, Inc. II Oct-02-2008
8 Mani, Inc. - Kiyohara Facility II Jan-11-2012
9 Silhouette Lift, Inc. II Jul-23-2015
10 Telefelx Medical II Aug-26-2010
11 Teleflex Creek Dr II Jul-17-2007
12 Teleflex Medical II May-07-2014
13 Teleflex Medical II May-01-2014

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