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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device light, catheter, fiberoptic, glass, ureteral
Regulation Description Fiberoptic light ureteral catheter.
Product CodeFCS
Regulation Number 876.4020
Device Class 2


Premarket Reviews
ManufacturerDecision
APPLE MEDICAL CORP.
  SUBSTANTIALLY EQUIVALENT 1
COOK, INC.
  SUBSTANTIALLY EQUIVALENT 1
LASER PERIPHERALS LLC.
  SUBSTANTIALLY EQUIVALENT 1
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 3

Device Problems
Heat 1
Kinked 1
Melted 1
Overheating of device or device component 1
Material separation 1
Unknown (for use when the device problem is not known) 1
Material perforation 1
Defective component 1
Total Device Problems 8

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 1 0 0 0 0 0 0 0 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Stryker Endoscopy II Sep-16-2008

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