510(k) K253663

Zeta Navigation System by Zeta Surgical, Inc. — Product Code HAW

K253663 is an FDA 510(k) premarket notification submitted by Zeta Surgical, Inc. for the device "Zeta Navigation System". The FDA issued a decision of Substantially Equivalent on May 1, 2026. The device falls under product code HAW (Neurological Stereotaxic Instrument), a Class II device regulated under 21 CFR 882.4560. Zeta Surgical, Inc. has at least 5 other 510(k) clearances on record.