• 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, natural
Regulation Description Absorbable surgical gut suture.
Product CodeGAL
Regulation Number 878.4830
Device Class 2


Premarket Reviews
ManufacturerDecision
AESCULAP
  SUBSTANTIALLY EQUIVALENT 1
ARC MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
COVIDIEN
  SUBSTANTIALLY EQUIVALENT 1
DEMETECH CORP.
  SUBSTANTIALLY EQUIVALENT 1
ETHICON
  SUBSTANTIALLY EQUIVALENT 1
SERRAL, S.A. DE C.V.
  SUBSTANTIALLY EQUIVALENT 1
SUTURTEK INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1
UNITED MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
UNITED STATES SURGICAL
  SUBSTANTIALLY EQUIVALENT 1
  3

Device Problems
Break 211
No code available 39
Other (for use when an appropriate device code cannot be identified) 37
Material frayed 28
Fluid leak 18
Material integrity issue 16
Failure to Adhere or Bond 15
Detachment of device component 11
Device operates differently than expected 11
Reaction 11
Packaging issue 9
Manufacturing or shipping issue associated with device 9
Detachment of device or device component 8
Leak 7
Implant extrusion 6
No Known Device Problem 5
Defective item 4
Knotted 4
Crack 4
Bent 4
Absorption 3
Difficult to open or close 3
Incorrect device or component shipped 3
Material twisted 3
Torn material 2
Device markings issue 2
Material deformation 2
Device Issue 2
Needle, separation 2
Unsealed device packaging 2
Product quality issue 2
Loose or intermittent connection 1
Migration of device or device component 1
Coiled 1
Degraded 1
Material disintegration 1
Entrapment of device or device component 1
Dull 1
Incorrect or inadequate test results 1
Misfire 1
Material rupture 1
Material separation 1
Unraveled material 1
Item contaminated during manufacturing or shipping 1
Defective component 1
Component missing 1
Device misassembled during manufacturing or shipping 1
Mechanics altered 1
Total Device Problems 500

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

Recalls
Manufacturer Recall Class Date Posted
1 Ethicon, Inc. II Jun-25-2015

-
-