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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device cannula, sinus
Regulation Description Manual surgical instrument for general use.
Product CodeKAM
Regulation Number 878.4800
Device Class 1


Premarket Reviews
ManufacturerDecision
ACCLARENT, INC.
  SUBSTANTIALLY EQUIVALENT 8
BOSTON MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
MICROMEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 2
XOMED, INC.
  SUBSTANTIALLY EQUIVALENT 3

Device Problems
Detachment of device or device component 6
No Known Device Problem 5
Unsealed device packaging 2
Shelf life exceeded 1
Material fragmentation 1
Total Device Problems 15

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 1 0

Recalls
Manufacturer Recall Class Date Posted
1 Acclarent, Inc. III Jun-09-2015
2 Surgical Instrument Service And Savings, Inc. II Jul-01-2013

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