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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device endoscopic ultrasound system, gastroenterology-urology
Regulation Description Endoscope and accessories.
Definition To provide ultrasonic visualization of body cavities that can be accessed by endoscope. For reusable, flexible endoscopes in this product code, validated reprocessing instructions and reprocessing validation data must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
Product CodeODG
Regulation Number 876.1500
Device Class 2


Premarket Reviews
ManufacturerDecision
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 6
OLYMPUS
  SUBSTANTIALLY EQUIVALENT 6
PENTAX
  SUBSTANTIALLY EQUIVALENT 10

Device Problems
No Known Device Problem 17
Device Cleaning Issue 6
Detachment of device or device component 5
Device markings issue 4
Device packaging compromised 2
Foreign material present in device 2
Disinfection or Sterilization Issue at User Location 2
No display or display failure 2
Leak 1
Migration of device or device component 1
Unsealed device packaging 1
Difficult to position 1
Material puncture 1
Material separation 1
Material perforation 1
Device contamination with blood or blood product 1
Obstruction within device 1
Failure to align 1
Break 1
Detachment of device component 1
Device operates differently than expected 1
Scratched material 1
No Information 1
Total Device Problems 55

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

Recalls
Manufacturer Recall Class Date Posted
1 Olympus Corporation of the Americas II Sep-28-2015
2 Pentax Medical Company II Jul-23-2016
3 Pentax of America Inc II Aug-23-2017

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