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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device camera, television, endoscopic, without audio
Regulation Description Surgical camera and accessories.
Product CodeFWF
Regulation Number 878.4160
Device Class 1


Premarket Reviews
ManufacturerDecision
ASPEN LABORATORIES
  SUBSTANTIALLY EQUIVALENT 1
FRIGITRONICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
KARL STORZ GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 2
RICHARD WOLF
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Improper device output 3
Failure, intermittent 2
Image display error 2
No device output 2
Component(s), overheating of 1
Interference 1
Total Device Problems 11

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

Recalls
Manufacturer Recall Class Date Posted
1 Smith & Nephew, Inc Endoscopy Division III May-05-2007

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