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510(k) Data Aggregation

    K Number
    K243271
    Device Name
    MENTOR™ MemoryShape™ Resterilizable Gel Breast Implant Sizer; MENTOR™ MemoryGel™ Resterilizable Gel Breast Implant Sizer; MENTOR™ MemoryGel™ Enhance Single Use Gel Sizer
    Manufacturer
    Mentor Worldwide, LLC
    Date Cleared
    2025-01-13

    (89 days)

    Product Code
    MRD
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    Mentor Worldwide, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MENTOR™ MemoryShape™ Resterilizable Gel Breast Implant Sizer is indicated for temporary insertion intraoperatively to evaluate the size and shape of the MemoryShape™ breast implant to be implanted. The MENTOR™ MemoryGel™ Resterilizable Gel Breast Implant Sizer is indicated for temporary insertion intraoperatively to evaluate the size and shape of the MemoryGel™ breast implant to be implanted. The MENTOR™ MemoryGel™ Enhance Single Use Gel Breast Implant Sizer is indicated for single use only for temporary insertion intraoperatively to evaluate the shape and size of the MemoryGel™ Enhance Breast Implant to be implanted.
    Device Description
    The MENTOR™ MemoryShape™ Resterilizable Gel Breast Implant Sizer STERILE (Gel Sizer) is designed for temporary intra-operative placement in the surgically prepared breast pocket. The Gel Sizer is used to evaluate the appropriate breast implant size and shape for each patient prior to implantation of a MemoryShape™ (contour shape) breast implant. The Gel Sizer is provided sterile and can be used out of the box for the initial use. The Gel Sizer is then resterilized 9 additional times for a total of 10 uses. The MemoryShape™ sizers are offered in various sizes to match the corresponding MemoryShape™ breast implants. These gel sizers contain raised orientation marks on the anterior and posterior of the device to help the physician with placement. The MENTOR™ Resterilizable Gel Breast Implant Sizer) is a silicone elastomer device, filled with silicone gel, that is designed for temporative placement in the surgically prepared breast pocket. The Sizer is used to evaluate the appropriate MemoryGel™ breast implant size and shape for each patient prior to implantation of a breast implant. It is provided non-sterile and must be sterilized prior to use. The Sizer should not be sterilized more than ten times. The MENTOR™ MemoryGel™ Enhance Single Use Gel Breast Implant Sizer (Sizer) is a silicone elastomer device, filled with silicone gel, that is designed for temporary intra operative placement in the surgically prepared breast pocket. The Sizer is used to evaluate the appropriate MemoryGel™ Breast lmplant size and shape for each patient prior to implantation of a breast implant. It is provided sterile and is for single use only. The Sizer should not be resterilized.
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