The following data is part of a premarket notification filed by Clearpoint Neuro, Inc. with the FDA for Clearpoint System.
| Device ID | K222519 |
| 510k Number | K222519 |
| Device Name: | ClearPoint System |
| Classification | Neurological Stereotaxic Instrument |
| Applicant | ClearPoint Neuro, Inc. 5 Musick Irvine, CA 92618 |
| Contact | Mary McNamara-Cullinane |
| Correspondent | John J Smith Hogan Lovells US LLP 555 Thirteenth Street NW Washington, DC 20004 |
| Product Code | HAW |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-08-19 |
| Decision Date | 2022-09-16 |