• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search Back To Search Results
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
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 1
GYRUS ACMI, INC.
  SUBSTANTIALLY EQUIVALENT 1
KARL STORZ GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 4
KENDALL
  SUBSTANTIALLY EQUIVALENT 1
MAXXIM MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
  SUBSTANTIALLY EQUIVALENT 1
OLYMPUS
  SUBSTANTIALLY EQUIVALENT 2
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
No Known Device Problem 40
Device Cleaning Issue 18
Bacterial contamination of device 9
Disinfection or Sterilization Issue at User Location 8
Break 8
Normal 5
No Information 4
Poor quality image 3
Device disinfection or sterilization issue 3
Hole in material 3
Material fragmentation 2
No display or display failure 2
No code available 2
Device handling issue 1
Device operates differently than expected 1
Material Distortion 1
Malfunction 1
Physical resistance 1
Defective item 1
Folded 1
Buckled material 1
Entrapment of device or device component 1
Failure to fold 1
Contamination during use 1
Degraded 1
Disinfection, inadequate/improper 1
Material disintegration 1
Difficult to insert 1
Kinked 1
Leak 1
Misconnection 1
Difficult to remove 1
Tip breakage 1
Use of Device Issue 1
Other (for use when an appropriate device code cannot be identified) 1
Device damaged prior to use 1
Arcing at electrodes 1
Total Device Problems 131

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 0 0 0 0 0
Class II 0 0 0 0 0 0 0 0 1 2
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Customed, Inc II Apr-14-2016
2 Customed, Inc II Sep-03-2015
3 Pentax Medical Company II Jun-28-2016

-
-