K251748
- 510(k) number
- K251748
- Device name
- MammoSTAR Biopsy Site Identifier
- Applicant
- Carbon Medical Technologies, Inc. MN · US
- Product code
- NEU — Marker, Radiographic, Implantable
- Decision date
- 2025-07-23
- Date received
- 2025-06-06
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 2.4 MB · U.S. public domain
Also available from FDA: K251748.pdf
Official FDA record: K251748
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.