510(k) Report

Devices descending from K212158

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K232615LumiMARK™ Biopsy Site Marker (LM0215T (Tulip Shape)); LumiMARK™ Biopsy Site Marker…Devicor Medical Products, Inc.20240—
+1K221961HydroMARK Plus Breast Biopsy Site MarkerDevicor Medical Products, Inc.20232—
+2K253761HydroMARK™ Plus Breast Biopsy Site Marker (Dragonfly Shape); HydroMARK™ Plus Breast…Devicor Medical Products, Inc.20260—
+2K240527HydroMARK™ Plus Breast Biopsy Site Marker (Hummingbird Shape) (4010-02-15-T6)Devicor Medical Products, Inc.20240—