510(k) K223552

Brainlab Elements – Trajectory Planning (2.6), Elements Stereotaxy, Elements Lead Localization, Elements Trajectory Planning Cranial by Brainlab AG — Product Code HAW

K223552 is an FDA 510(k) premarket notification submitted by Brainlab AG for the device "Brainlab Elements – Trajectory Planning (2.6), Elements Stereotaxy, Elements Lead Localization, Elements Trajectory Planning Cranial". The FDA issued a decision of Substantially Equivalent on Apr 19, 2023. The device falls under product code HAW (Neurological Stereotaxic Instrument), a Class II device regulated under 21 CFR 882.4560. Brainlab AG has 141 other 510(k) clearances on record.