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

    MammoSTAR Biopsy Site Identifier

    K Number: K251748 · Decision Jul 23, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    102
    Registration Numbers
    102
    Same Product Code
    109
    Applicant Total
    17
    Review Days
    47

    Basic Information

    Device Name
    MammoSTAR Biopsy Site Identifier
    K Number
    K251748
    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
    Carbon Medical Technologies, Inc.
    Date Received
    June 6, 2025
    Decision Date
    July 23, 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

    VizMark Preloaded Tissue Marker Device (VM-0001)

    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 Carbon Medical Technologies, Inc.

    K Number Device Name
    K253598 InjecSURE Injection System
    K211590 Fiducial Marker
    K172227 Endoscopic Injection Needle
    K133148 BIOMARC COAXIAL NEEDLE
    K132064 BIOMARC FIDUCIAL MARKER
    K132708 BIOMARC FIDUCIAL MARKER
    K130678 BIOMARC GOLD FIDUCIAL MARKER
    K110772 BIOMARC FIDUCIAL MARKER
    K100994 PRELOADED TISSUE MARKER DEVICE
    K070436 BIOMARC GOLD TISSUE MARKER
    Search all 17 clearances from Carbon Medical Technologies, Inc. →