510(k) K241327

Navient Image Guide Navigation System (955-NC-NC), Cranial by Claronav — Product Code HAW

K241327 is an FDA 510(k) premarket notification submitted by Claronav for the device "Navient Image Guide Navigation System (955-NC-NC), Cranial". The FDA issued a decision of Substantially Equivalent on February 5, 2025. The device falls under product code HAW (Neurological Stereotaxic Instrument), a Class II device regulated under 21 CFR 882.4560. Claronav has at least 5 other 510(k) clearances on record.