K251989
- 510(k) number
- K251989
- Device name
- VizMark Preloaded Tissue Marker Device (VM-0001)
- Applicant
- Breast-Med, Inc. MN · US
- Product code
- NEU — Marker, Radiographic, Implantable
- Decision date
- 2025-12-12
- Date received
- 2025-06-27
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K251989.pdf
Official FDA record: K251989
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.