Esophageal, Mucosal, Electrical Characterization
The Esophageal Mucosal Electrical Characterization device, also known as the esophageal tissue characterization system, is intended for obtaining measurements of electrical properties within esophageal tissue to aid in diagnostic assessment of the esophageal mucosa. It is classified as FDA Class 2, requiring 510(k) clearance, regulated under 21 CFR 876.1450 within the Gastroenterology and Urology medical specialty. The product code is QIS. The device is not an implant and is not flagged as life-sustaining.
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Basic Information
- Product Code
- QIS
- Device Class
- FDA class 2
- Regulation Number
- 876.1450
- Medical Specialty
- Gastroenterology, Urology
- Review Panel
- GU
- Submission Type
- 1
Device Characteristics
Definition
The esophageal tissue characterization system is intended for obtaining measurements of electrical properties within esophageal tissue.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K233974 | Mucosal Impedance Measurement System | Sep 06, 2024 | Substantially Equivalent | Alandra Medical Sapi DE CV |
| K230056 | MiVu Esophageal Endo Cap | Apr 25, 2023 | Substantially Equivalent | Diversatek Healthcare |
| DEN180067 | Mucosal Integrity Conductivity (MI) Test System | Dec 23, 2019 | Unknown | Diversatek Healthcare, Inc. |
FEI Numbers
This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.