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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device light source, fiberoptic, routine
Regulation Description Endoscope and accessories.
Product CodeFCW
Regulation Number 876.1500
Device Class 2


Premarket Reviews
ManufacturerDecision
IBA
  SUBSTANTIALLY EQUIVALENT 1
INTEGRA
  SUBSTANTIALLY EQUIVALENT 1
KARL STORZ GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 2
MAXXIM MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
RICHARD WOLF
  SUBSTANTIALLY EQUIVALENT 1
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 1
SUNOPTIC TECHNOLOGIES, LLC
  SUBSTANTIALLY EQUIVALENT 1
UNITED STATES SURGICAL
  SUBSTANTIALLY EQUIVALENT 1
WELCH ALLYN, INC.
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Burn of device or device component 13
Electrical issue 5
Dislodged or dislocated 4
No Known Device Problem 4
Device-device incompatibility 2
No Information 2
Device operates differently than expected 2
Device inoperable 2
Explode 2
Fluid leak 1
Hole in material 1
Normal 1
Device emits odor 1
Overheating of device or device component 1
Smoking 1
Use of Device Issue 1
Improper or incorrect procedure or method 1
Other (for use when an appropriate device code cannot be identified) 1
Obstruction within device 1
Split 1
Device sensing issue 1
Failure to shut off 1
Power source issue 1
Total Device Problems 50

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

Recalls
Manufacturer Recall Class Date Posted
1 Integra LifeSciences Corp. II Dec-02-2011
2 Integra LifeSciences Corp. II Apr-25-2011

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