Clearance Summary
Uterine ElevatOR PRO with OccludOR Balloon received FDA 510(k) clearance under submission number K220202, sponsored by The O R Company 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 2022-03-31.
- Submission: K220202
- Applicant / Sponsor: The O R Company Pty, Ltd.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.4530
- Decision date: 2022-03-31
Classification & Regulation
This clearance is catalogued under FDA product code LKF and 21 CFR 884.4530, within the Obstetrics/Gynecology review panel as a Class II device.