• 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, nonabsorbable, synthetic, polyester
Regulation Description Nonabsorbable poly(ethylene terephthalate) surgical suture.
Product CodeGAS
Regulation Number 878.5000
Device Class 2


Premarket Reviews
ManufacturerDecision
ARTHREX, INC.
  SUBSTANTIALLY EQUIVALENT 1
INTERNACIONAL FARMACEUTICA, S.A. DE C.V.
  SUBSTANTIALLY EQUIVALENT 1
PHOENIX BIOMEDICAL
  1
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 1
UNITED STATES SURGICAL
  1
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Device, or device fragments remain in patient 57
Break 52
Other (for use when an appropriate device code cannot be identified) 38
Failure to deploy 26
Unknown (for use when the device problem is not known) 13
Reaction 11
Device Issue 8
No Known Device Problem 5
Difficult to deploy 4
Needle, separation 3
Wire(s), breakage of 2
Dull 2
Difficult to position 2
Premature deployment 2
Failure to deliver 2
Deployment issue 2
No code available 2
Component missing 1
Particulates 1
Material frayed 1
Product quality issue 1
Source, detachment from 1
Implant extrusion 1
Defective item 1
Absorption 1
Device, removal of (non-implant) 1
Detachment of device component 1
Total Device Problems 241

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

Recalls
Manufacturer Recall Class Date Posted
1 Surgical Instrument Service And Savings, Inc. II Jul-01-2013

-
-