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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device enteroscope and accessories
Regulation Description Endoscope and accessories.
Definition To provide visualization and perform various procedures within the small intestine.
Product CodeFDA
Regulation Number 876.1500
Device Class 2


Premarket Reviews
ManufacturerDecision
OLYMPUS
  SUBSTANTIALLY EQUIVALENT 1
SPIRUS MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
TRIMEDYNE, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
No Known Device Problem 3
No Information 2
Misconnection 2
Use of Device Issue 2
Detachment of device component 1
No display or display failure 1
Inflation issue 1
No code available 1
Total Device Problems 13

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