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

    MENTOR™ MemoryGel™ Enhance Single Use Gel Sizer

    K Number: K241552 · Decision Sep 6, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    12
    Applicant Total
    12
    Review Days
    98

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    Basic Information

    Device Name
    MENTOR™ MemoryGel™ Enhance Single Use Gel Sizer
    K Number
    K241552
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Mentor Worldwide, LLC
    Date Received
    May 31, 2024
    Decision Date
    September 6, 2024
    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

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    Mentor MemoryShape Resterilizable Gel Breast Implant Sizer STERILE

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    FDA 510(k)
    FDA Unclassified ·Unknown
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    Other Clearances by Mentor Worldwide, LLC

    K Number Device Name
    K242963 MENTOR™ PliaForm™ Breast Tissue Expander w/ Suture Tabs
    K243271 MENTOR™ MemoryShape™ Resterilizable Gel Breast Implant Sizer; MENTOR™ MemoryGel™ Resterilizable Gel Breast Implant Sizer; MENTOR™ MemoryGel™ Enhance Single Use Gel Sizer
    K243836 Mentor™ CPX ™ 4 PLUS Enhance Breast Tissue Expander
    K241918 MENTOR™ CPX™4 PLUS Enhance Breast Tissue Expander
    K182335 CPX 4 Breast Tissue Expander with Smooth Surface
    K161176 ARTOURA Breast Tissue Expanders with Smooth Surface
    K152496 CPX 4 Breast Tissue Expander
    K151055 Mentor MemoryShape Resterilizable Gel Breast Implant Sizer STERILE
    K150777 Artoura Breast Tissue Expander
    K142998 CPX Control Breast Tissue Expander
    Search all 12 clearances from Mentor Worldwide, LLC →