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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
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 1
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 5
CANDELA CORP.
  SUBSTANTIALLY EQUIVALENT 1
KARL STORZ GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 8
MAXXIM MEDICAL
  SUBSTANTIALLY EQUIVALENT 4
MEDICAL ENGINEERING CORP.
  SUBSTANTIALLY EQUIVALENT 3
OLYMPUS
  SUBSTANTIALLY EQUIVALENT 2
PENTAX
  SUBSTANTIALLY EQUIVALENT 1
RICHARD WOLF
  SUBSTANTIALLY EQUIVALENT 3
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 3
SURGITEK
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Break 27
No display or display failure 20
No Known Device Problem 8
Material perforation 7
No device output 5
Material deformation 5
Material Protrusion 5
Leak 4
Detachment of device component 4
Bent 3
Fracture 3
Material fragmentation 3
Peeled 3
Mechanical issue 3
Kinked 3
Device or device component damaged by another device 3
Improper device output 3
Material puncture 2
Disinfection or Sterilization Issue at User Location 2
Device Contamination with biological material 2
Device operates differently than expected 2
Bacterial contamination of device 2
False device output 2
Hole in material 2
Incorrect display 2
Entrapment of device or device component 1
Crack 1
Material disintegration 1
Blockage within device or device component 1
Burn of device or device component 1
Difficult to insert 1
Fluid leak 1
Material frayed 1
Heat 1
Tear, rip or hole in device packaging 1
Cut in material 1
Physical resistance 1
Device displays error message 1
Device maintenance issue 1
Material rigid or stiff 1
Material separation 1
Melted 1
Misfocusing 1
Poor quality image 1
Normal 1
Material Distortion 1
Material integrity issue 1
Optical issue 1
Output issue 1
Device handling issue 1
Total Device Problems 150

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 0 0 0 0 0 0 0 0
Class II 0 0 0 0 0 0 0 0 0 1 0
Class III 0 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Pentax Medical Company II Jun-28-2016

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