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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.
Product CodeODG
Regulation Number 876.1500
Device Class 2


Premarket Reviews
ManufacturerDecision
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 2
PENTAX
  SUBSTANTIALLY EQUIVALENT 3

Device Problems
Device markings issue 4
No Known Device Problem 3
Detachment of device or device component 2
No display or display failure 2
Leak 1
Unsealed device packaging 1
Material puncture 1
Material separation 1
Failure to align 1
Device Cleaning Issue 1
Device operates differently than expected 1
Scratched material 1
Total Device Problems 19

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