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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device accessories, catheter, g-u
Regulation Description Urological catheter and accessories.
Product CodeKNY
Regulation Number 876.5130
Device Class 2


Premarket Reviews
ManufacturerDecision
ACMI CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
APPLIED MEDICAL RESOURCES CORP.
  SUBSTANTIALLY EQUIVALENT 1
AVAIL MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 2
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 2
COOK, INC.
  SUBSTANTIALLY EQUIVALENT 1
KENDALL
  SUBSTANTIALLY EQUIVALENT 2
LAKE REGION MEDICAL
  SUBSTANTIALLY EQUIVALENT 3
MANAN MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
MAXXIM MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
MEDICAL DEVICE TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 2
MEMCATH TECHNOLOGIES LLC.
  SUBSTANTIALLY EQUIVALENT 1
MENTOR CORP.
  SUBSTANTIALLY EQUIVALENT 1
NORTH AMERICAN STERILIZATION & PACKAGING CO.
  SUBSTANTIALLY EQUIVALENT 1
SURGITEK
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Break 8
Detachment of device component 5
Peeled 4
Device, or device fragments remain in patient 4
Tip breakage 3
Material separation 2
Device damaged prior to use 2
Wire(s), breakage of 2
Device Issue 2
Material frayed 2
Inflation issue 1
Migration of device or device component 1
Delivered as unsterile product 1
Normal 1
Unsealed device packaging 1
Difficult to position 1
Material fragmentation 1
Split 1
Buckled material 1
Device operates differently than expected 1
No Known Device Problem 1
Unknown (for use when the device problem is not known) 1
Material perforation 1
Balloon burst 1
Total Device Problems 48

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

Recalls
Manufacturer Recall Class Date Posted
1 Gyrus Acmi, Incorporated II May-26-2011

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