510(k) K233144
K233144 is an FDA 510(k) premarket notification submitted by ClearPoint Neuro, Inc. for the device "ClearPoint Bone Screw Fiducials". The FDA issued a decision of Substantially Equivalent on January 12, 2024. The device falls under product code HAW (Neurological Stereotaxic Instrument), a Class II device regulated under 21 CFR 882.4560. ClearPoint Neuro, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 12, 2024
- Date Received
- September 27, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Neurological Stereotaxic Instrument
- Device Class
- Class II
- Regulation Number
- 882.4560
- Review Panel
- NE
- Submission Type