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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device endoscopic video imaging system/component, gastroenterology-urology
Regulation Description Endoscope and accessories.
Definition To allow for visualization of body cavities through an endoscope by projecting images to a monitor.
Product CodeFET
Regulation Number 876.1500
Device Class 2


Premarket Reviews
ManufacturerDecision
GREATBATCH SCIENTIFIC
  SUBSTANTIALLY EQUIVALENT 1
KARL STORZ GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 5
MEDLINE
  SUBSTANTIALLY EQUIVALENT 1
OLYMPUS
  SUBSTANTIALLY EQUIVALENT 2
RICHARD WOLF
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
No display or display failure 7
Circuit Failure 4
Loss of power 3
Device damaged prior to use 2
Spark 2
No code available 1
High test results 1
Arcing 1
Failure to power-up 1
Break 1
Burn of device or device component 1
Fire 1
Fracture 1
Poor quality image 1
Total Device Problems 27

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