• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search Back To Search Results
Device endoscopic video imaging system/component, gastroenterology-urology
Regulation Description Endoscope and accessories.
Definition To allow for visualization of body cavities through an endoscope by projecting images to a monitor.
Product CodeFET
Regulation Number 876.1500
Device Class 2


Premarket Reviews
ManufacturerDecision
FUJI
  SUBSTANTIALLY EQUIVALENT 1
GIMMI GMBH
  SUBSTANTIALLY EQUIVALENT 1
GREATBATCH SCIENTIFIC
  SUBSTANTIALLY EQUIVALENT 1
HILL-ROM, INC.
  SUBSTANTIALLY EQUIVALENT 1
KARL STORZ GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 15
MEDLINE
  SUBSTANTIALLY EQUIVALENT 1
OLYMPUS
  SUBSTANTIALLY EQUIVALENT 6
PENTAX
  SUBSTANTIALLY EQUIVALENT 1
RICHARD WOLF
  SUBSTANTIALLY EQUIVALENT 3
SCHOLLY FIBEROPTIC
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 1
SOPRO
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
No display or display failure 9
Poor quality image 5
Circuit Failure 4
Loss of power 3
Device operates differently than expected 3
Spark 2
No Known Device Problem 2
Failure to power-up 2
Device damaged prior to use 2
Residue after decontamination 2
Erratic display 2
Artifact 2
Break 2
Burn of device or device component 2
Image display error 2
Moisture damage 1
Fire 1
Fracture 1
High test results 1
Arcing 1
Inappropriate shock 1
Power source issue 1
No code available 1
Connection issue 1
Electrical power problem 1
Total Device Problems 54

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

Recalls
Manufacturer Recall Class Date Posted
1 Fujifilm Medical Systems U.S.A., Inc. II Sep-22-2015
2 Karl Storz Endoscopy II Jul-06-2016

-
-