510(k) K243945

ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit) by SurGenTec, LLC — Product Code KNW

K243945 is an FDA 510(k) premarket notification submitted by SurGenTec, LLC for the device "ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit)". The FDA issued a decision of Substantially Equivalent on April 24, 2025. The device falls under product code KNW (Instrument, Biopsy), a Class II device regulated under 21 CFR 876.1075. SurGenTec, LLC has at least 10 other 510(k) clearances on record.