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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device endoscopic injection needle, gastroenterology-urology
Regulation Description Endoscope and accessories.
Definition inserted through endoscope for injection of a solution, gas, or implantable materials into gi or gu tissue.
Product CodeFBK
Regulation Number 876.1500
Device Class 2


Premarket Reviews
ManufacturerDecision
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 3
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 2
CARBON MEDICAL TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 3
COLOPLAST MANUFACTURING US LLC
  SUBSTANTIALLY EQUIVALENT 1
COOK, INC.
  SUBSTANTIALLY EQUIVALENT 2
KARL STORZ GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 1
OLYMPUS
  SUBSTANTIALLY EQUIVALENT 1
VANCE PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
WILSON COOK MEDICAL
  SUBSTANTIALLY EQUIVALENT 4

Device Problems
No Known Device Problem 20
Retraction problem 18
Break 6
Difficult to insert 4
Failure to deploy 2
Device operates differently than expected 2
Difficult to position 1
Difficult to remove 1
Tears, rips, holes in device, device material 1
Device handling issue 1
Total Device Problems 56

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 0 0 0 0
Class III 0 0 0 0 0 0 0 0 0 0


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