510(k) K251748

MammoSTAR Biopsy Site Identifier by Carbon Medical Technologies, Inc. — Product Code NEU

K251748 is an FDA 510(k) premarket notification submitted by Carbon Medical Technologies, Inc. for the device "MammoSTAR Biopsy Site Identifier". The FDA issued a decision of Substantially Equivalent on July 23, 2025. The device falls under product code NEU (Marker, Radiographic, Implantable), a Class II device regulated under 21 CFR 878.4300. Carbon Medical Technologies, Inc. has at least 10 other 510(k) clearances on record.