Clearance Summary
SPHINCTER OF ODDI MANOMETRIC (SOM) SYSTEM received FDA 510(k) clearance under submission number K120524, sponsored by Mui Scientific. 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 2012-06-21.
- Submission: K120524
- Applicant / Sponsor: Mui Scientific
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1725
- Decision date: 2012-06-21
Classification & Regulation
This clearance is catalogued under FDA product code FFX and 21 CFR 876.1725, within the Gastroenterology, Urology review panel as a Class II device.