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TPLC
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Device
gastrointestinal motility system, capsule
Definition
Used to evaluate GI motility disorders and indicated for use in evaluating patients with suspected motility disorders.
Product Code
NYV
Regulation Number
876.1725
Device Class
2
Premarket Reviews
Manufacturer
Decision
THE SMARTPILL CORPORATION
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2015
2
2
2016
2
2
2017
2
2
2019
2
2
2020
1
1
2021
1
1
2022
3
3
2023
1
1
2024
9
9
Device Problems
MDRs with this Device Problem
Events in those MDRs
Entrapment of Device
7
7
Contamination /Decontamination Problem
7
7
Adverse Event Without Identified Device or Use Problem
4
4
Device Contaminated During Manufacture or Shipping
2
2
Unintended Application Program Shut Down
1
1
Loss of Data
1
1
Patient-Device Incompatibility
1
1
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
Radiation Exposure, Unintended
3
3
Abdominal Pain
2
2
Patient Problem/Medical Problem
1
1
Nausea
1
1
No Known Impact Or Consequence To Patient
1
1
Vomiting
1
1
Pain
1
1
Stenosis
1
1
Ulcer
1
1
Urinary Tract Infection
1
1
Unintended Radiation Exposure
1
1
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