Clearance Summary
ClearPoint System (Software Version 3.0) received FDA 510(k) clearance under submission number K243657, sponsored by ClearPoint Neuro, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2025-01-24.
- Submission: K243657
- Applicant / Sponsor: ClearPoint Neuro, Inc.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.4560
- Decision date: 2025-01-24
Classification & Regulation
This clearance is catalogued under FDA product code HAW and 21 CFR 882.4560, within the Neurology review panel as a Class II device.