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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 K223864
Device Name Alignment System Cranial, Alignment Software Cranial, Cirq Alignment Software Cranial Biopsy, Cirq Alignment Software Cranial sEEG, Varioguide Alignment Software Cranial
Applicant
Brainlab AG
Olof-Palme-Str.9
Munich,  DE 81829
Applicant Contact Esther Moreno Garcia
Correspondent
Brainlab AG
Olof-Palme-Str.9
Munich,  DE 81829
Correspondent Contact Esther Moreno Garcia
Regulation Number882.4560
Classification Product Code
HAW  
Date Received12/23/2022
Decision Date 09/09/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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