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

    Intraoperative, Single-Use, Sterile, Silicone Breast Sizer Motiva Implant Matrix

    K Number: K183163 · Decision Feb 5, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    12
    Applicant Total
    2
    Review Days
    82

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    Intraoperative, Single-Use, Sterile, Silicone Breast Sizer Motiva Implant Matrix
    K Number
    K183163
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Motiva USA, LLC
    Date Received
    November 15, 2018
    Decision Date
    February 5, 2019
    Product Code
    MRD
    Advisory Committee
    Unknown
    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
    MRD Mammary Sizer

    Similar 510(k) Clearances

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

    MENTOR™ MemoryShape™ Resterilizable Gel Breast Implant Sizer; MENTOR™ MemoryGel™ Resterilizable Gel Breast Implant Sizer; MENTOR™ MemoryGel™ Enhance Single Use Gel Sizer

    FDA 510(k)
    FDA Unclassified ·Unknown

    MENTOR™ MemoryGel™ Enhance Single Use Gel Sizer

    FDA 510(k)
    FDA Unclassified ·Unknown

    NATRELLE INSPIRA Single Use Sizers for Gel Implants

    FDA 510(k)
    FDA Unclassified ·Unknown

    Sientra OPUS Silicone Gel Breast Implant Sizer

    FDA 510(k)
    FDA Unclassified ·Unknown

    Mentor MemoryShape Resterilizable Gel Breast Implant Sizer STERILE

    FDA 510(k)
    FDA Unclassified ·Unknown

    MENTOR MEMORYSHAPE RESTERILIZABLE GEL SIZER

    FDA 510(k)
    FDA Unclassified ·Unknown
    View all

    Other Clearances by Motiva USA, LLC

    K Number Device Name
    K211676 Motiva Flora SmoothSilk Tissue Expander