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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device ureteroscope and accessories, flexible/rigid
Regulation Description Endoscope and accessories.
Definition To perform various diagnostic and therapeutic procedures within the urinary tract.
Product CodeFGB
Regulation Number 876.1500
Device Class 2


Premarket Reviews
ManufacturerDecision
ACMI CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 3
CANDELA CORP.
  SUBSTANTIALLY EQUIVALENT 1
KARL STORZ GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 5
MAXXIM MEDICAL
  SUBSTANTIALLY EQUIVALENT 4
MEDICAL ENGINEERING CORP.
  SUBSTANTIALLY EQUIVALENT 1
OLYMPUS
  SUBSTANTIALLY EQUIVALENT 2
PENTAX
  SUBSTANTIALLY EQUIVALENT 1
RICHARD WOLF
  SUBSTANTIALLY EQUIVALENT 2
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 3
SURGITEK
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
No display or display failure 11
Material Protrusion 2
Detachment of device component 1
Entrapment of device or device component 1
Fluid leak 1
Heat 1
Difficult to insert 1
Normal 1
Peeled 1
Material puncture 1
Material separation 1
Physical resistance 1
Total Device Problems 23

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