K243657
- 510(k) number
- K243657
- Device name
- ClearPoint System (Software Version 3.0)
- Applicant
- ClearPoint Neuro, Inc. CA · US
- Product code
- HAW — Neurological Stereotaxic Instrument
- Decision date
- 2025-01-24
- Date received
- 2024-11-27
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
510(k) Summary (official FDA PDF): K243657.pdf
Official FDA record: K243657
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.