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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device gastrointestinal motility system, capsule
Regulation Description Gastrointestinal motility monitoring system.
Definition Used to evaluate GI motility disorders and indicated for use in evaluating patients with suspected motility disorders.
Product CodeNYV
Regulation Number 876.1725
Device Class 2


Premarket Reviews
ManufacturerDecision
ANX ROBOTICA CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
ATMO BIOSCIENCES LTD
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 1 1
2021 1 1
2022 3 3
2023 1 1
2024 9 9
2025 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Contamination /Decontamination Problem 7 7
Entrapment of Device 6 6
Device Contaminated During Manufacture or Shipping 2 2
Loss of Data 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 9 9
Foreign Body In Patient 5 5
Abdominal Pain 1 1
Ulcer 1 1
Urinary Tract Infection 1 1
Unintended Radiation Exposure 1 1

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