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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device syringe, irrigating (non dental)
Regulation Description Irrigating syringe.
Product CodeKYZ
Regulation Number 880.6960
Device Class 1


Premarket Reviews
ManufacturerDecision
MICROMEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 4
SHIPPERT MEDICAL TECHNOLOGIES CORP.
  SUBSTANTIALLY EQUIVALENT 2
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 1
SUB-Q, INC.
  SUBSTANTIALLY EQUIVALENT 2
WELCH ALLYN, INC.
  SUBSTANTIALLY EQUIVALENT 1
WELCON, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Break 4
Disconnection 4
Device packaging compromised 1
Total Device Problems 9

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

Recalls
Manufacturer Recall Class Date Posted
1 C.R. Bard, Inc. III Feb-16-2016
2 Customed, Inc II Apr-14-2016
3 Customed, Inc II Sep-03-2015
4 Customed, Inc II Mar-21-2012
5 Haemacure Corporation II May-11-2012
6 Medtronic Neurosurgery II Jul-25-2013
7 Micromedics, Inc. I Nov-18-2010

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