510(k) K242575

Stereotaxic Guiding Surgical Devices, NaoTrac S by Brain Navi Biotechnology Co., Ltd. — Product Code HAW

K242575 is an FDA 510(k) premarket notification submitted by Brain Navi Biotechnology Co., Ltd. for the device "Stereotaxic Guiding Surgical Devices, NaoTrac S". The FDA issued a decision of Substantially Equivalent on May 23, 2025. The device falls under product code HAW (Neurological Stereotaxic Instrument), a Class II device regulated under 21 CFR 882.4560.