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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device instrument, ent manual surgical
Regulation Description Ear, nose, and throat manual surgical instrument.
Product CodeLRC
Regulation Number 874.4420
Device Class 1


Premarket Reviews
ManufacturerDecision
ACCLARENT, INC.
  SUBSTANTIALLY EQUIVALENT 9
ARTHROCARE CORP.
  SUBSTANTIALLY EQUIVALENT 1
ENTELLUS MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 21
ENTRIGUE SURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
HELIX MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 2
Symbiosis Corp.
  SUBSTANTIALLY EQUIVALENT 1
UNITED STATES SURGICAL
  SUBSTANTIALLY EQUIVALENT 3
XOMED, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
No Known Device Problem 34
Break 20
Unsealed device packaging 5
Tip breakage 5
Material fragmentation 4
Bent 4
Detachment of device or device component 3
Material rupture 2
Overheating of device or device component 2
Material puncture 1
Difficult to remove 1
Burn of device or device component 1
Burst 1
Detachment of device component 1
Material separation 1
Sticking 1
Malfunction 1
Material integrity issue 1
No Information 1
Total Device Problems 89

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 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Gyrus Acmi, Incorporated II May-31-2013

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