510(k) K253379

Stealth AXiS Cranial clinical application by Medtronic Navigation, Inc. — Product Code HAW

K253379 is an FDA 510(k) premarket notification submitted by Medtronic Navigation, Inc. for the device "Stealth AXiS Cranial clinical application". The FDA issued a decision of Substantially Equivalent on March 26, 2026. The device falls under product code HAW (Neurological Stereotaxic Instrument), a Class II device regulated under 21 CFR 882.4560. Medtronic Navigation, Inc. has at least 10 other 510(k) clearances on record.