510(k) Report

Devices descending from K121113

10 later devices reach Biopsy Sciences, Inc. Hydromark Brest Biosy Site Marker through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K210752HydroMARK Breast Biopsy Site MarkerDevicor Medical Products, Inc.202151
+1K161021HydroMARK Breast Biopsy Site MarkerDevicor Medical Products, Inc.20162—
+1K130537Biopsy Sciences LLC Hydromark Breast Biopsy Site MarkerBiopsy Sciences, LLC20133—
+2K212158HydroMARK Breast Biopsy Site MarkerDevicor Medical Products, Inc.202241
+2K203097HydroMARK Breast Biopsy Site MarkersDevicor Medical Products, Inc.20200—
+2K170803HydroMARK Breast Biopsy Site MarkersDevicor Medical Products, Inc.20170—
+3K232615LumiMARK™ Biopsy Site Marker (LM0215T (Tulip Shape)); LumiMARK™ Biopsy Site Marker…Devicor Medical Products, Inc.20240—
+3K221961HydroMARK Plus Breast Biopsy Site MarkerDevicor Medical Products, Inc.20232—
+4K253761HydroMARK™ Plus Breast Biopsy Site Marker (Dragonfly Shape); HydroMARK™ Plus Breast…Devicor Medical Products, Inc.20260—
+4K240527HydroMARK™ Plus Breast Biopsy Site Marker (Hummingbird Shape) (4010-02-15-T6)Devicor Medical Products, Inc.20240—