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

    MENTOR MEMORYSHAPE RESTERILIZABLE GEL SIZER

    K Number: K131853 · Decision Jul 17, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    12
    Applicant Total
    12
    Review Days
    26

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    Basic Information

    Device Name
    MENTOR MEMORYSHAPE RESTERILIZABLE GEL SIZER
    K Number
    K131853
    Device Class
    FDA unclassified
    Clearance Type
    Special
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Mentor Worldwide, LLC
    Date Received
    June 21, 2013
    Decision Date
    July 17, 2013
    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

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

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    Mentor MemoryShape Resterilizable Gel Breast Implant Sizer STERILE

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    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
    K241552 MENTOR™ MemoryGel™ Enhance Single Use Gel Sizer
    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
    Search all 12 clearances from Mentor Worldwide, LLC →