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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device bur, ear, nose and throat
Regulation Description Ear, nose, and throat bur.
Product CodeEQJ
Regulation Number 874.4140
Device Class 1


Premarket Reviews
ManufacturerDecision
CMSI
  SUBSTANTIALLY EQUIVALENT 1
KARL STORZ GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 3
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 1
MICROMEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
SPIRE CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
XOMED, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Break 57
Burrs, breakage of 9
Tip breakage 9
Material fragmentation 6
Component(s), broken 2
Insufficient cooling 2
Vibration 2
Improper or incorrect procedure or method 1
Device operates differently than expected 1
Mechanical jam 1
No Known Device Problem 1
Fracture 1
Use of Device Issue 1
Detachment of device component 1
Inability to irrigate 1
Misconnection 1
Normal 1
Total Device Problems 97

Recalls
  2007 2008 2009 2010 2011 2012 2013
Class I 0 0 0 0 0 0 0
Class II 0 0 0 0 0 0 0
Class III 0 0 0 0 0 0 0


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