510(k) Report

Devices descending from K130537

3 later devices reach Biopsy Sciences LLC Hydromark Breast Biopsy Site Marker through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K161021HydroMARK Breast Biopsy Site MarkerDevicor Medical Products, Inc.20162—
+2K203097HydroMARK Breast Biopsy Site MarkersDevicor Medical Products, Inc.20200—
+2K170803HydroMARK Breast Biopsy Site MarkersDevicor Medical Products, Inc.20170—