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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Neurological Stereotaxic Instrument
510(k) Number K232102
Device Name ClearPoint Array System (Version 1.2)
Applicant
ClearPoint Neuro, Inc.
5 Musick
Irvine,  CA  92618
Applicant Contact Brennan Sullivan
Correspondent
ClearPoint Neuro, Inc.
5 Musick
Irvine,  CA  92618
Correspondent Contact Brennan Sullivan
Regulation Number882.4560
Classification Product Code
HAW  
Date Received07/14/2023
Decision Date 09/15/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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