QIS — Esophageal, Mucosal, Electrical Characterization Class II
FDA product code QIS covers "Esophageal, Mucosal, Electrical Characterization", a Class II medical device regulated under 21 CFR 876.1450. Submissions are reviewed by the Gastroenterology, Urology panel. At least 3 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- QIS
- Device Class
- Class II
- Regulation Number
- 876.1450
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
Definition
The esophageal tissue characterization system is intended for obtaining measurements of electrical properties within esophageal tissue.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K233974 | alandra medical sapi de cv | Mucosal Impedance Measurement System | September 6, 2024 |
| K230056 | diversatek healthcare | MiVu Esophageal Endo Cap | April 25, 2023 |
| DEN180067 | diversatek healthcare | Mucosal Integrity Conductivity (MI) Test System | December 23, 2019 |