Alignment System Cranial, Alignment Software Cranial, Cirq Alignment Software Cranial Biopsy, Cirq Alignment Software Cranial sEEG, Varioguide Alignment Software Cranial

About This 510(k) Submission

K223864 is an FDA 510(k) clearance for the Alignment System Cranial, Alignment Software Cranial, Cirq Alignment Software Cranial Biopsy, Cirq Alignment Software Cranial sEEG, Varioguide Alignment Software Cranial, a Neurological Stereotaxic Instrument (Class II — Special Controls, product code HAW), submitted by Brainlab AG (Munich, DE). The FDA issued a Cleared decision on September 9, 2023, 260 days after receiving the submission on December 23, 2022. This device falls under the Neurology review panel. Regulated under 21 CFR 882.4560.