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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device cystourethroscope
Regulation Description Endoscope and accessories.
Product CodeFBO
Regulation Number 876.1500
Device Class 2


Premarket Reviews
ManufacturerDecision
AMERICAN MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
KARL STORZ GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 5
OLYMPUS
  SUBSTANTIALLY EQUIVALENT 1
RICHARD WOLF
  SUBSTANTIALLY EQUIVALENT 2
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 1
SURGITEK
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Material separation 7
Detachment of device component 3
Break 2
Normal 2
Difficult to remove 2
Wire(s), breakage of 2
Spark 1
Flare or flash 1
No Known Device Problem 1
Tip breakage 1
Bent 1
Material disintegration 1
Flaked 1
Total Device Problems 25

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