Clearance Summary
MyOnyx System received FDA 510(k) clearance under submission number K201014, sponsored by Thought Technology , Ltd.. 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 2021-01-13.
- Submission: K201014
- Applicant / Sponsor: Thought Technology , Ltd.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5320
- Decision date: 2021-01-13
Classification & Regulation
This clearance is catalogued under FDA product code KPI and 21 CFR 876.5320, within the Gastroenterology, Urology review panel as a Class II device.