510(k) K253856

Geniant Cranial (Navigated Neurosurgical Positioning Robot) by Koh Young Technology, Inc. — Product Code HAW

K253856 is an FDA 510(k) premarket notification submitted by Koh Young Technology, Inc. for the device "Geniant Cranial (Navigated Neurosurgical Positioning Robot)". The FDA issued a decision of Substantially Equivalent on September 10, 2026. The device falls under product code HAW (Neurological Stereotaxic Instrument), a Class II device regulated under 21 CFR 882.4560. Koh Young Technology, Inc. has at least 1 other 510(k) clearance on record.