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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device endoscopic guidewire, gastroenterology-urology
Regulation Description Endoscope and accessories.
Definition To provide access to gi or gu tract for the purpose of passing or exchanging other accessories.
Product CodeOCY
Regulation Number 876.1500
Device Class 2


Premarket Reviews
ManufacturerDecision
ACCELLENT
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 5
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 2
COLOPLAST MANUFACTURING US LLC
  SUBSTANTIALLY EQUIVALENT 2
CONMED
  SUBSTANTIALLY EQUIVALENT 1
COOK, INC.
  SUBSTANTIALLY EQUIVALENT 1
INAMED CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
LAKE REGION MEDICAL
  SUBSTANTIALLY EQUIVALENT 5
NIPRO CORP
  SUBSTANTIALLY EQUIVALENT 1
OLYMPUS
  SUBSTANTIALLY EQUIVALENT 1
RADIUS MEDICAL TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
TERUMO CARDIOVASCULAR SYSTEMS
  SUBSTANTIALLY EQUIVALENT 2
WILSON COOK MEDICAL
  SUBSTANTIALLY EQUIVALENT 4

Device Problems
Detachment of device component 282
Peeled 86
Material separation 27
Migration of device or device component 9
Break 7
Flaked 5
No Known Device Problem 4
Fracture 3
Improper or incorrect procedure or method 3
Other (for use when an appropriate device code cannot be identified) 2
Wire(s), breakage of 2
Cut in material 2
Material frayed 2
Material disintegration 2
Material deformation 2
Device operates differently than expected 2
Device-device incompatibility 2
Dislodged or dislocated 1
Source, detachment from 1
Unraveled material 1
Material integrity issue 1
Material Protrusion 1
Dissection 1
Material fragmentation 1
Component(s), broken 1
Component falling 1
Bent 1
User used incorrect product for intended use 1
Device, or device fragments remain in patient 1
Detachment of device or device component 1
Total Device Problems 455

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 0 0 0 0 0 0 0 0
Class II 0 0 0 0 0 0 0 1 0 0 0
Class III 0 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 NEO METRICS, INC. II Jun-10-2014

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