• 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, polyethylene
Regulation Description Nonabsorbable poly(ethylene terephthalate) surgical suture.
Product CodeGAT
Regulation Number 878.5000
Device Class 2


Premarket Reviews
ManufacturerDecision
AESCULAP
  SUBSTANTIALLY EQUIVALENT 2
ANULEX TECHNOLOGIES, INC
  SUBSTANTIALLY EQUIVALENT 4
ARC MEDICAL
  1
ARTHREX, INC.
  SE - WITH LIMITATIONS 1
  SUBSTANTIALLY EQUIVALENT 11
ARTHROCARE CORP.
  SUBSTANTIALLY EQUIVALENT 2
ARTHROTEK, INC.
  SUBSTANTIALLY EQUIVALENT 1
AXYA MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 3
BIOMET
  SUBSTANTIALLY EQUIVALENT 1
CAYENNE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 3
CONMED
  SUBSTANTIALLY EQUIVALENT 1
COVIDIEN
  SUBSTANTIALLY EQUIVALENT 2
DEMETECH CORP.
  SUBSTANTIALLY EQUIVALENT 1
EDWARDS LIFESCIENCES
  SUBSTANTIALLY EQUIVALENT 1
FOURNITURES HOSPITALIERES INDUSTRIE
  SUBSTANTIALLY EQUIVALENT 1
GENZYME CORPORATION
  1
  SUBSTANTIALLY EQUIVALENT 3
LSI SOLUTIONS
  SUBSTANTIALLY EQUIVALENT 1
MANI, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 1
MUSCULOSKELETAL TRANSPLANT FOUNDATION
  SUBSTANTIALLY EQUIVALENT 2
NEOTRACT, INC.
  SUBSTANTIALLY EQUIVALENT 3
OPUSMED INC.
  SUBSTANTIALLY EQUIVALENT 1
PETERS SURGICAL
  SUBSTANTIALLY EQUIVALENT 1
SENTREHEART INC.
  SUBSTANTIALLY EQUIVALENT 3
SERRAL, S.A. DE C.V.
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 10
SORIN
  SUBSTANTIALLY EQUIVALENT 1
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 2
SURGICAL SPECIALTIES CORP.
  SUBSTANTIALLY EQUIVALENT 1
TELEFLEX MEDICAL
  SUBSTANTIALLY EQUIVALENT 6
UNITED MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
UNITED STATES SURGICAL
  1
  SUBSTANTIALLY EQUIVALENT 2
USCI ANGIOGRAPHY DIVISION
  SUBSTANTIALLY EQUIVALENT 4
XIROS PLC
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Break 95
Deployment issue 46
Failure to deploy 38
No code available 25
Device operates differently than expected 25
Premature deployment 22
Other (for use when an appropriate device code cannot be identified) 19
Detachment of device component 15
Dislodged or dislocated 13
Device Issue 10
Failure to Adhere or Bond 9
Device, or device fragments remain in patient 8
No Known Device Problem 8
Detachment of device or device component 8
Component falling 8
Misfire 6
Failure to fire 6
Unknown (for use when the device problem is not known) 5
Component missing 4
Material integrity issue 4
Improper or incorrect procedure or method 4
Loose or intermittent connection 4
No Information 4
Packaging issue 3
Defective item 3
Needle, separation 3
Sticking 3
Battery charger, defective 3
Difficult to remove 3
Self-activation or keying 3
Difficult to deploy 2
Material frayed 2
Retraction problem 2
Bent 2
Suture line separation 2
Material fragmentation 2
Incomplete or missing packaging 2
Source, detachment from 2
Material perforation 1
Cut in material 1
Slippage of device or device component 1
Component(s), broken 1
Positioning Issue 1
Material erosion 1
Flaked 1
Design/structure problem 1
Failure to form staple 1
Device packaging compromised 1
Mechanical jam 1
Material deformation 1
Material disintegration 1
Migration of device or device component 1
Device inoperable 1
Unstable 1
Loss of or failure to bond 1
Structural problem 1
Difficult to open or close 1
Total Device Problems 442

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 1 0 0 1 0 1 0 3 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 Innovatech Medical Resources L.P. II Jan-11-2012
3 Peters Surgical II Sep-22-2014
4 Smith & Nephew, Inc. II Jun-22-2015
5 Smith & Nephew, Inc. Endoscopy Division II Nov-18-2010
6 Teleflex Medical II May-07-2014
7 Teleflex Medical II Mar-26-2014

-
-