BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    VizMark Preloaded Tissue Marker Device (VM-0001)

    K Number: K251989 · Decision Dec 12, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    102
    Registration Numbers
    102
    Same Product Code
    109
    Applicant Total
    2
    Review Days
    168

    Basic Information

    Device Name
    VizMark Preloaded Tissue Marker Device (VM-0001)
    K Number
    K251989
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4300
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Breast-Med, Inc.
    Date Received
    June 27, 2025
    Decision Date
    December 12, 2025
    Product Code
    NEU
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    NEU Marker, Radiographic, Implantable

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (NEU), ordered by most recent decision date.

    HydroMARK™ Plus Breast Biopsy Site Marker (Dragonfly Shape); HydroMARK™ Plus Breast Biopsy Site Marker (Hummingbird Shape)

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    MOLLI 2 System

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    SCOUT MD Surgical Guidance System

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    MammoSTAR Biopsy Site Identifier

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    UltraCor™ Twirl™ Breast Tissue Marker

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    SmartClip Secure Soft Tissue Marker

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery
    View all

    Other Clearances by Breast-Med, Inc.

    K Number Device Name
    K133697 BREAST-MED TISSUE MARKER