Brainlab Elements ? Trajectory Planning (2.6), Elements Stereotaxy, Elements Lead Localization, Elements Trajectory Planning Cranial

About This 510(k) Submission

K223552 is an FDA 510(k) clearance for the Brainlab Elements ? Trajectory Planning (2.6), Elements Stereotaxy, Elements Lead Localization, Elements Trajectory Planning 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 April 19, 2023, 145 days after receiving the submission on November 25, 2022. This device falls under the Neurology review panel. Regulated under 21 CFR 882.4560.