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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device endoscope, neurological
Regulation Description Neurological endoscope.
Product CodeGWG
Regulation Number 882.1480
Device Class 2


Premarket Reviews
ManufacturerDecision
  SUBSTANTIALLY EQUIVALENT 1
AESCULAP
  SUBSTANTIALLY EQUIVALENT 7
CODMAN & SHURTLEFF, INC.
  SUBSTANTIALLY EQUIVALENT 3
ENDIUS, INC.
  SUBSTANTIALLY EQUIVALENT 1
JOHNSON & JOHNSON
  SUBSTANTIALLY EQUIVALENT 1
KARL STORZ GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 8
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 4
OLYMPUS
  SUBSTANTIALLY EQUIVALENT 3
PENUMBRA, INC.
  SUBSTANTIALLY EQUIVALENT 2
RICHARD WOLF
  SUBSTANTIALLY EQUIVALENT 3
SOFAMOR DANEK
  SUBSTANTIALLY EQUIVALENT 1
UNITED STATES SURGICAL
  SUBSTANTIALLY EQUIVALENT 1
VISIONSENSE, LTD.
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Device operates differently than expected 4
Material Protrusion 3
Poor quality image 3
Break 2
Fracture 2
Image resolution poor 2
Pumping issue 2
Melted 2
Material integrity issue 2
Failure to conduct 2
Failure to deliver energy 1
False positive result 1
Inadequate user interface 1
Device handling issue 1
Kinked 1
Leak 1
Device clogged 1
Bent 1
Loss of or failure to bond 1
Overheating of device or device component 1
Loss of power 1
Device Difficult to Setup or Prepare 1
Device, or device fragments remain in patient 1
Use of Device Issue 1
Vibration 1
Defective component 1
Out-of-box failure 1
Solder joint failure 1
Failure to disconnect 1
Date-related software issue 1
Total Device Problems 44

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 3 0 0 0 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Geomed Medizin-Technik Gmbh & Co. II Feb-19-2012
2 Mitaka USA, Inc. II May-11-2012
3 Visionsense, Ltd. II Mar-08-2012

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