• 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 cannula, surgical, general & plastic surgery
Regulation Description Manual surgical instrument for general use.
Product CodeGEA
Regulation Number 878.4800
Device Class 1


Premarket Reviews
ManufacturerDecision
AESCULAP
  SUBSTANTIALLY EQUIVALENT 1
AXIOM
  SUBSTANTIALLY EQUIVALENT 2
BYRON MEDICAL
  1
CONMED
  SUBSTANTIALLY EQUIVALENT 1
COOPERVISION
  SUBSTANTIALLY EQUIVALENT 1
ETHICON
  SUBSTANTIALLY EQUIVALENT 3
GENICON
  SUBSTANTIALLY EQUIVALENT 1
LIFESTREAM INT'L, INC.
  SUBSTANTIALLY EQUIVALENT 1
UNITED STATES SURGICAL
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Tear, rip or hole in device packaging 27
Break 17
No code available 9
Detachment of device component 3
Component falling 2
Bent 2
Unknown (for use when the device problem is not known) 2
Device or device fragments location unknown 2
Device, removal of (non-implant) 2
Not Applicable 2
Buckled material 1
Device operates differently than expected 1
Dislodged or dislocated 1
Item contaminated during manufacturing or shipping 1
Material deformation 1
Mechanical jam 1
No Known Device Problem 1
Component(s), broken 1
Crack 1
Fracture 1
Material fragmentation 1
Replace 1
Tip breakage 1
Total Device Problems 81

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

Recalls
Manufacturer Recall Class Date Posted
1 Biomet, Inc. II May-26-2016
2 Genico, Inc., dba Genicon II Dec-24-2008
3 MicroAire Surgical Instruments, LLC II Apr-05-2016

-
-