The following data is part of a premarket notification filed by Clearpoint Neuro, Inc. with the FDA for Clearpoint Array System.
| Device ID | K202575 |
| 510k Number | K202575 |
| Device Name: | ClearPoint Array System |
| Classification | Neurological Stereotaxic Instrument |
| Applicant | ClearPoint Neuro, Inc. 5 Musick Irvine, CA 92618 |
| Contact | Pete Piferi |
| Correspondent | John Smith Hogan Lovells US LLP 555 Thirteenth St. NW Washington, DC 20004 |
| Product Code | HAW |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-09-04 |
| Decision Date | 2021-01-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850376007611 | K202575 | 000 |
| 00850376007598 | K202575 | 000 |
| 00850376007604 | K202575 | 000 |
| 00850376007628 | K202575 | 000 |
| 00850376007635 | K202575 | 000 |
| 00850359007744 | K202575 | 000 |
| 00850359007904 | K202575 | 000 |
| 00850359007911 | K202575 | 000 |
| 00850359007928 | K202575 | 000 |
| 00850359007935 | K202575 | 000 |
| 00850376007710 | K202575 | 000 |