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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device confocal optical imaging
Regulation Description Endoscope and accessories.
Definition Collection of light signals for visualization of cellular microstructures.
Product CodeOWN
Regulation Number 876.1500
Device Class 2


Premarket Reviews
ManufacturerDecision
INTUITIVE SURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
KARL STORZ GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 1
MAUNA KEA TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 8
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
No display or display failure 1
Loss of power 1
Failure to power-up 1
Total Device Problems 3

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