510(k) Report

Devices descending from K221961

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

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