510(k) K212158

HydroMARK Breast Biopsy Site Marker by Devicor Medical Products, Inc. — Product Code NEU

K212158 is an FDA 510(k) premarket notification submitted by Devicor Medical Products, Inc. for the device "HydroMARK Breast Biopsy Site Marker". The FDA issued a decision of Substantially Equivalent on April 21, 2022. The device falls under product code NEU (Marker, Radiographic, Implantable), a Class II device regulated under 21 CFR 878.4300. Devicor Medical Products, Inc. has at least 10 other 510(k) clearances on record.