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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device cystoscope and accessories, flexible/rigid
Regulation Description Endoscope and accessories.
Definition To examine and perform procedures within the urinary tract.
Product CodeFAJ
Regulation Number 876.1500
Device Class 2


Premarket Reviews
ManufacturerDecision
ACMI CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
ARTES MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
GYRUS ACMI, INC.
  SUBSTANTIALLY EQUIVALENT 1
KARL STORZ GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 3
MAXXIM MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
  SUBSTANTIALLY EQUIVALENT 1
OLYMPUS
  SUBSTANTIALLY EQUIVALENT 1
OPTUS, INC.
  SUBSTANTIALLY EQUIVALENT 1
PENTAX
  SUBSTANTIALLY EQUIVALENT 1
PROSURG, INC.
  SUBSTANTIALLY EQUIVALENT 2
RICHARD WOLF
  SUBSTANTIALLY EQUIVALENT 2
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 1
VISION-SCIENCES, INC.
  SUBSTANTIALLY EQUIVALENT 3

Device Problems
Device Cleaning Issue 6
Normal 5
Break 3
No Information 3
Poor quality image 2
No display or display failure 2
Hole in material 2
Difficult to insert 1
Kinked 1
Leak 1
Misconnection 1
Contamination during use 1
Disinfection, inadequate/improper 1
Difficult to remove 1
Tip breakage 1
Other (for use when an appropriate device code cannot be identified) 1
Device damaged prior to use 1
Malfunction 1
Physical resistance 1
Defective item 1
Buckled material 1
Total Device Problems 37

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