Clearance Summary
LIBERTY Endovascular Robotic System (LIBERTYOS) received FDA 510(k) clearance under submission number K243789, sponsored by Microbot Medical , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2025-09-04.
- Submission: K243789
- Applicant / Sponsor: Microbot Medical , Ltd.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1290
- Decision date: 2025-09-04
Classification & Regulation
This clearance is catalogued under FDA product code DXX and 21 CFR 870.1290, within the Cardiovascular review panel as a Class II device.