Clearance Summary
ELLAVI UBT received FDA 510(k) clearance under submission number K230849, sponsored by Sinapi Biomedical (Pty) , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Obstetrics/Gynecology review panel. The statutory decision date of record is 2023-11-13.
- Submission: K230849
- Applicant / Sponsor: Sinapi Biomedical (Pty) , Ltd.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.4530
- Decision date: 2023-11-13
Classification & Regulation
This clearance is catalogued under FDA product code OQY and 21 CFR 884.4530, within the Obstetrics/Gynecology review panel as a Class II device.