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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device nasopharyngoscope (flexible or rigid)
Regulation Description Nasopharyngoscope (flexible or rigid) and accessories.
Product CodeEOB
Regulation Number 874.4760
Device Class 2


Premarket Reviews
ManufacturerDecision
ACCLARENT, INC.
  SUBSTANTIALLY EQUIVALENT 4
ENDIUS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ENTELLUS MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
GYRUS ACMI, INC.
  SUBSTANTIALLY EQUIVALENT 1
INVOTEC INTERNATIONAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
J. JAMNER
  SUBSTANTIALLY EQUIVALENT 2
KARL STORZ GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 25
OLYMPUS
  SUBSTANTIALLY EQUIVALENT 7
OPTIM, INC.
  SUBSTANTIALLY EQUIVALENT 1
OPTUS, INC.
  SUBSTANTIALLY EQUIVALENT 1
PENTAX
  SUBSTANTIALLY EQUIVALENT 2
PRECISION OPTICS CORP.
  SUBSTANTIALLY EQUIVALENT 1
RICHARD WOLF
  SUBSTANTIALLY EQUIVALENT 2
RTC INC.-MEMCATH TECHNOLOGIES LLC
  SUBSTANTIALLY EQUIVALENT 1
SCHOLLY FIBEROPTIC
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 1
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 1
VISION-SCIENCES, INC.
  SUBSTANTIALLY EQUIVALENT 15
VISIONSENSE, LTD.
  SUBSTANTIALLY EQUIVALENT 1
XION GMBH
  SUBSTANTIALLY EQUIVALENT 1
XOMED, INC.
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Material rupture 2
Smoking 1
Device inoperable 1
Battery issue 1
Charging issue 1
Device operates differently than expected 1
Foreign material present in device 1
Material deformation 1
No Known Device Problem 1
Scratched material 1
Temperature issue 1
Torn material 1
Device Cleaning Issue 1
Hole in material 1
Poor quality image 1
Retraction problem 1
Total Device Problems 17

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

Recalls
Manufacturer Recall Class Date Posted
1 Vision-Sciences, Inc. II Jan-29-2012

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