Home / 510(k) Clearances / K223864

510(k) K223864

Alignment System Cranial, Alignment Software Cranial, Cirq Alignment Software Cranial Biopsy, Cirq Alignment Software Cranial sEEG, Varioguide Alignment Software Cranial by Brainlab AG — Product Code HAW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 9, 2023
Date Received
December 23, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Neurological Stereotaxic Instrument
Device Class
Class II
Regulation Number
882.4560
Review Panel
NE
Submission Type

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