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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device orally ingested transient device for constipation
Definition An orally ingested transient device for constipation is an electric swallowable capsule that naturally passes through the gastrointestinal tract for the treatment of constipation.
Product CodeQTN
Regulation Number 876.5940
Device Class 2


Premarket Reviews
ManufacturerDecision
VIBRANT LTD.
  GRANTED 1
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2024 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Patient Device Interaction Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Choking 2 2
Constipation 2 2

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