510(k) Report

Devices descending from K042290

3 later devices reach Vacuum Assisted Core Biopsy Device through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K180233Eviva Stereotactic Guided Breast Biopsy SystemHologic, Inc.20180—
+1K163052Brevera Biopsy System with Corlumina Imaging TechnologyHologic, Inc.201711
+2K262792Brevera Biopsy System with CorLumina Imaging Technology (BREVDISP09)Hologic, Inc.20260—