510(k) K262792

Brevera Biopsy System with CorLumina Imaging Technology (BREVDISP09) by Hologic, Inc. — Product Code KNW

K262792 is an FDA 510(k) premarket notification submitted by Hologic, Inc. for the device "Brevera Biopsy System with CorLumina Imaging Technology (BREVDISP09)". The FDA issued a decision of Substantially Equivalent on August 12, 2026. The device falls under product code KNW (Instrument, Biopsy), a Class II device regulated under 21 CFR 876.1075. Hologic, Inc. has at least 10 other 510(k) clearances on record.