Clearance Summary
Mucosal Impedance Measurement System received FDA 510(k) clearance under submission number K233974, sponsored by Alandra Medical Sapi DE CV. The device was reviewed via the Traditional premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 2024-09-06.
- Submission: K233974
- Applicant / Sponsor: Alandra Medical Sapi DE CV
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1450
- Decision date: 2024-09-06
Classification & Regulation
This clearance is catalogued under FDA product code QIS and 21 CFR 876.1450, within the Gastroenterology, Urology review panel as a Class II device.