Device Classification Name |
Neurological Stereotaxic Instrument
|
510(k) Number |
K222519 |
Device Name |
ClearPoint System |
Applicant |
ClearPoint Neuro, Inc. |
5 Musick |
Irvine,
CA
92618
|
|
Applicant Contact |
Mary McNamara-Cullinane |
Correspondent |
Hogan Lovells US LLP |
555 Thirteenth Street NW |
Washington,
DC
20004
|
|
Correspondent Contact |
John J Smith |
Regulation Number | 882.4560
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 08/19/2022 |
Decision Date | 09/16/2022 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|