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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device tray, catheterization, sterile urethral, with or without catheter (kit)
Regulation Description Urological catheter and accessories.
Product CodeFCM
Regulation Number 876.5130
Device Class 2


Premarket Reviews
ManufacturerDecision
ABCO DEALERS, INC.
  SUBSTANTIALLY EQUIVALENT 1
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 1
COLOPLAST MANUFACTURING US LLC
  SUBSTANTIALLY EQUIVALENT 1
CONTINENTAL MEDICAL LABORATORIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
DEROYAL
  SUBSTANTIALLY EQUIVALENT 1
GO MEDICAL INDUSTRIES PTY. LTD.
  SUBSTANTIALLY EQUIVALENT 2
HOSPIRA INC.
  SUBSTANTIALLY EQUIVALENT 3
MALLINCKRODT
  SUBSTANTIALLY EQUIVALENT - KIT WITH DRUGS 1
MENTOR CORP.
  SUBSTANTIALLY EQUIVALENT 1
RUSCH, INC.
  SUBSTANTIALLY EQUIVALENT 2
SNYDER LABORATORIES, INC.
  SUBSTANTIALLY EQUIVALENT 3
SUPERIOR HEALTHCARE GROUP, INC.
  SUBSTANTIALLY EQUIVALENT - WITH DRUG 1
TRINITY
  SUBSTANTIALLY EQUIVALENT 1
WELCON, INC.
  SUBSTANTIALLY EQUIVALENT - KIT WITH DRUGS 1

Device Problems
Inaccurate flowrate 2
Difficult to remove 1
Tears, rips, holes in device, device material 1
Device inoperable 1
Use of Device Issue 1
Component missing 1
Device operates differently than expected 1
Balloon rupture 1
Bent 1
Component(s), broken 1
Deflation issue 1
Total Device Problems 12

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

Recalls
Manufacturer Recall Class Date Posted
1 Customed, Inc II Mar-21-2012
2 Go Medical Industries Pty., Ltd. II Oct-21-2011
3 Nurse Assist, Inc II May-25-2011
4 Teleflex Medical III Aug-06-2014

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