510(k) K232102
K232102 is an FDA 510(k) premarket notification submitted by ClearPoint Neuro, Inc. for the device "ClearPoint Array System (Version 1.2)". The FDA issued a decision of Substantially Equivalent on September 15, 2023. 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
- September 15, 2023
- Date Received
- July 14, 2023
- Clearance Type
- Special
- 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