ClearPoint Neuro, Inc.
FDA 510(k) & PMA Approved Devices — 11 products
Total Devices11
Categories2
Latest FDA decision2025-01-24
SEC Filings: 1 filings on record. Latest: 8-K (2026-08-03). View on SEC EDGAR →
| Type | Number | Device Name | Code | Date | Actions |
|---|---|---|---|---|---|
| 510(k) | K243657 | ClearPoint System (Software Version 3.0) | HAW | 2025-01-24 | View |
| 510(k) | K233703 | Bone Anchor (NGS-BA-01) | HAW | 2024-04-26 | View |
| 510(k) | K233141 | SmartFrame OR | HAW | 2024-01-12 | View |
| 510(k) | K233144 | ClearPoint Bone Screw Fiducials | HAW | 2024-01-12 | View |
| 510(k) | K233155 | ClearPointer Optical Navigation Wand | HAW | 2024-01-12 | View |
| 510(k) | K233243 | ClearPoint System (Software Version 2.2) | HAW | 2023-11-27 | View |
| 510(k) | K232102 | ClearPoint Array System (Version 1.2) | HAW | 2023-09-15 | View |
| 510(k) | K222519 | ClearPoint System | HAW | 2022-09-16 | View |
| 510(k) | K213645 | ClearPoint Maestro Brain Model | QIH | 2022-08-08 | View |
| 510(k) | K214040 | ClearPoint Array System (version 1.1) | HAW | 2022-04-12 | View |
| 510(k) | K202575 | ClearPoint Array System | HAW | 2021-01-22 | View |
No matching devices.