• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search Back To Search Results
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 1166
Other (for use when an appropriate device code cannot be identified) 641
Reaction 236
Needle, separation 212
No code available 203
Failure to Adhere or Bond 190
No Known Device Problem 99
Bent 58
Absorption 55
Device operates differently than expected 48
Packaging issue 43
Detachment of device component 33
Material integrity issue 29
Detachment of device or device component 28
Unknown (for use when the device problem is not known) 27
Defective item 20
No Information 15
Material frayed 14
Battery charger, defective 13
Product quality issue 13
Device or device fragments location unknown 12
Device markings issue 11
Material deformation 10
Failure to unwrap 10
Degraded 10
Manufacturing or shipping issue associated with device 8
Defective component 7
Material disintegration 7
Knotted 7
Device remains implanted 7
Device misassembled during manufacturing or shipping 6
Tear, rip or hole in device packaging 6
Patient-device incompatibility 6
Component missing 5
Implant extrusion 5
Difficult to open or remove packaging material 5
Tip breakage 5
Material fragmentation 5
Unraveled material 4
Migration of device or device component 4
Nonstandard device or device component 4
Incomplete or missing packaging 4
Device packaging compromised 4
Incompatibility problem 3
Item contaminated during manufacturing or shipping 3
Material perforation 3
Device damaged prior to use 2
Delivered as unsterile product 2
Loss of or failure to bond 2
Device Issue 2
Out-of-box failure 1
Device displays error message 1
Device, removal of (non-implant) 1
Folded 1
Delamination 1
Cut in material 1
Mechanical jam 1
Naturally worn 1
Incorrect device or component shipped 1
Torn material 1
Component falling 1
Failure to conduct 1
Failure to cycle 1
Kinked 1
Material erosion 1
Burst 1
Mechanical issue 1
Difficult to remove 1
Material rigid or stiff 1
Material separation 1
Slippage of device or device component 1
Total Device Problems 3333

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

-
-