510(k) Report

Devices descending from K161021

2 later devices reach HydroMARK Breast Biopsy Site Marker through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K203097HydroMARK Breast Biopsy Site MarkersDevicor Medical Products, Inc.20200—
+1K170803HydroMARK Breast Biopsy Site MarkersDevicor Medical Products, Inc.20170—