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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device endoscopic irrigation/suction system
Regulation Description Endoscope and accessories.
Definition To supply sterile water, other solutions and/or suction to endoscopes during endoscopic procedures.
Product CodeOCX
Regulation Number 876.1500
Device Class 2


Premarket Reviews
ManufacturerDecision
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 2
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 1
ENDIUS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ERBE ELEKTROMEDIZIN GMBH
  SUBSTANTIALLY EQUIVALENT 2
JOHNSON & JOHNSON
  SUBSTANTIALLY EQUIVALENT 1
KARL STORZ GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 4
MEDIVATORS REPROCESSING SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE
  SUBSTANTIALLY EQUIVALENT 1
NORTHGATE TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 2
PROMEDIC, INC.
  SUBSTANTIALLY EQUIVALENT 1
PROPPER MFG
  SUBSTANTIALLY EQUIVALENT 1
SUPERIOR HEALTHCARE GROUP, INC.
  SUBSTANTIALLY EQUIVALENT 1
SURGITEK
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Detachment of device component 2
Fluid leak 2
Material fragmentation 1
No Known Device Problem 1
Failure to pump 1
Total Device Problems 7

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

Recalls
Manufacturer Recall Class Date Posted
1 Baxter Healthcare Corp. II Jan-26-2015
2 US Endoscopy Group Inc II Jul-01-2015
3 US Endoscopy Group Inc II Apr-11-2013

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