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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device collector, urine, (and accessories) for indwelling catheter
Regulation Description Urine collector and accessories.
Product CodeKNX
Regulation Number 876.5250
Device Class 2


Premarket Reviews
ManufacturerDecision
ABCO DEALERS, INC.
  SUBSTANTIALLY EQUIVALENT 1
BEIERSDORF
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 1
BRISTOL-MYERS SQUIBB
  SUBSTANTIALLY EQUIVALENT 1
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 3
COLOPLAST MANUFACTURING US LLC
  SUBSTANTIALLY EQUIVALENT 5
E-Z-EM, INC.
  SUBSTANTIALLY EQUIVALENT 1
HOLLISTER, INC.
  SUBSTANTIALLY EQUIVALENT 4
INAMED CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
KENDALL
  SUBSTANTIALLY EQUIVALENT 12
MAERSK MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE
  SUBSTANTIALLY EQUIVALENT 4
NEOTECH PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
POST MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
SAGE PRODUCTS
  SUBSTANTIALLY EQUIVALENT 1
SIMPORT PLASTICS LTD
  SUBSTANTIALLY EQUIVALENT 1
SNYDER LABORATORIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
WELCON, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Blockage within device or device component 8
Fluid leak 4
No Known Device Problem 2
Tear, rip or hole in device packaging 2
Connection issue 1
Device operates differently than expected 1
Device packaging compromised 1
Infusion or flow issue 1
No flow 1
No Information 1
Restricted flowrate 1
Hole in material 1
Instruction for use issue 1
Leak 1
Occlusion within device 1
Overheating of device or device component 1
Material separation 1
Device damaged prior to use 1
Total Device Problems 30

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 1 0 2 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 C.R. Bard, Inc. II Apr-01-2015
2 Covidien LP II May-27-2011
3 Customed, Inc II Sep-03-2015
4 Teleflex Medical II Apr-22-2013

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