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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?
    Product Code :

    MRD

    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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    K Number
    K241552
    Device Name
    MENTOR™ MemoryGel™ Enhance Single Use Gel Sizer
    Manufacturer
    Mentor Worldwide LLC
    Date Cleared
    2024-09-06

    (98 days)

    Product Code
    MRD
    Regulation Number
    N/A
    Why did this record match?
    Product Code :

    MRD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    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 Implanted.
    Device Description
    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 intraoperative 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 sterile and is for single use only. The Sizer should not be resterilized.
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    K Number
    K203229
    Device Name
    NATRELLE INSPIRA Single Use Sizers for Gel Implants
    Manufacturer
    Allergan
    Date Cleared
    2021-06-02

    (212 days)

    Product Code
    MRD
    Regulation Number
    N/A
    Why did this record match?
    Product Code :

    MRD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    NATRELLE INSPIRA® Single Use Sizers are used during breast augmentation or reconstruction procedures to assist the surgeon in determining the appropriate size breast implant.
    Device Description
    NATRELLE INSPIRA® Single Use Sizers are designed for temporary intraoperative placement, to assist in determining the desired breast implant volume. They are used during breast augmentation or reconstruction procedures. NATRELLE INSPIRA® Single Use Sizers are constructed of a smooth silicone elastomer shell and are filled with responsive gel that contains the colorant cobalt aluminate blue spinel at a concentration of 0.1%. They have been designed to match the dimensions of the NATRELLE INSPIRA® breast implants. NATRELLE INSPIRA® Single Use Sizers are supplied sterile and are for single patient use, one sizer per breast.
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    K Number
    K200706
    Device Name
    Sientra OPUS Silicone Gel Breast Implant Sizer
    Manufacturer
    Sientra, Inc
    Date Cleared
    2020-11-16

    (243 days)

    Product Code
    MRD
    Regulation Number
    N/A
    Why did this record match?
    Product Code :

    MRD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Sientra OPUS® Silicone Gel Breast Implant Sizer is a single-use, sterile, intraoperative device indicated for temporary placement during breast augmentation or reconstruction procedures to assist the surgeon in determining the appropriate size of the long-term Sientra OPUS® Breast Implant to be implanted.
    Device Description
    The Sientra OPUS® Silicone Gel Breast Implant Sizer is a single-use, sterile, intraoperative device indicated for temporary placement during breast augmentation or reconstruction procedures to assist the surgeon in determining the appropriate size Sientra Breast Implant to be implanted. The Sientra Gel Sizers are designed to complement the portfolio of Sientra OPUS® Silicone Gel Breast Implants ("Breast Implants" or "Implants"), and are therefore available in the same range of styles, dimensions and fill volume as Sientra Implants. The Sientra OPUS® Silicone Gel Breast Implant Sizers are constructed with a smoothsurfaced, silicone elastomer shell and a filler made of clear, high-strength silicone gel. Sientra's Gel Sizers have been demonstrated to be biocompatible. The printing on the exterior of the Gel Sizer shell is clearly marked, "SIZER", "SINGLE USE ONLY", and "DO NOT IMPLANT", to clearly differentiate the Gel Sizers from Sientra's OPUS Breast Implants. Each Sientra Gel Sizer is dry-heat-sterilized, for single patient use only, and is not intended for long-term implantation or re-sterilization.
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    K Number
    K183163
    Device Name
    Intraoperative, Single-Use, Sterile, Silicone Breast Sizer Motiva Implant Matrix
    Manufacturer
    Motiva USA, LLC
    Date Cleared
    2019-02-05

    (82 days)

    Product Code
    MRD
    Regulation Number
    N/A
    Why did this record match?
    Product Code :

    MRD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Intraoperative, Single-use, Sterile, Silicone Breast Sizers Motiva Implant Matrix® are temporary intraoperative placement devices used during breast augmentation or reconstruction procedures to assist the surgeon in determining the appropriate size of the long-term breast implant to use.
    Device Description
    Intraoperative, Single-use, Sterile, Silicone Breast Sizers Motiva Implant Matrix® are sizing devices designed for temporary intraoperative placement, to assist in determining the desired breast implant volume and shape for each patient prior to implantation of a Motiva Implant Matrix® silicone breast implant. They are used during breast augmentation or reconstruction procedures. The Intraoperative, Single-use, Sterile, Silicone Breast Sizers Motiva Implant Matrix® are constructed with a low diffusion shell featuring a barrier layer between various layers of silicone elastomer to minimize gel diffusion; a patch, and cohesive restricted medical grade silicone gel, which is aimed for intraoperative temporary implantation only. The filling gel is tinted with pigments, in order for the Round Sizers to be clearly differentiated from the long term implantable devices. The Intraoperative, Single-use, Sterile, Silicone Breast Sizers Motiva Implant Matrix® have been designed to match every Motiva Implant Matrix® silicone breast implant reference, and are therefore available in the same range of bases or diameters, projections and volumes as the long term implants.
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    K Number
    K151055
    Device Name
    Mentor MemoryShape Resterilizable Gel Breast Implant Sizer STERILE
    Manufacturer
    MENTOR WORLDWIDE LLC
    Date Cleared
    2015-05-20

    (30 days)

    Product Code
    MRD
    Regulation Number
    N/A
    Why did this record match?
    Product Code :

    MRD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MENTOR® MemoryShape™ Resterilizable Gel Breast Implant Sizer is indicated for temporary insertion intra-operatively to evaluate the size and shape of the MemoryShape™ 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.
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    K Number
    K131853
    Device Name
    MENTOR MEMORYSHAPE RESTERILIZABLE GEL SIZER
    Manufacturer
    MENTOR WORLDWIDE LLC
    Date Cleared
    2013-07-17

    (26 days)

    Product Code
    MRD
    Regulation Number
    N/A
    Why did this record match?
    Product Code :

    MRD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Mentor Resterilizable MemoryShape™ Gel Sizer is indicated for temporary insertion intra-operatively to evaluate the size and shape of the MemoryShape™ breast implant to be implanted.
    Device Description
    The Mentor Resterilizable MemoryShape™ Gel Breast Implant Sizer (Gel Sizer) is designed for temporary intraoperative 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 non-sterile to be sterilized prior to initial use and 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.
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    K Number
    K062421
    Device Name
    MENTOR RESTERILIZABLE GEL BREAST IMPLANT SIZER
    Manufacturer
    MENTOR CORPORATION
    Date Cleared
    2006-10-10

    (53 days)

    Product Code
    MRD
    Regulation Number
    N/A
    Why did this record match?
    Product Code :

    MRD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Mentor 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.
    Device Description
    The Mentor Resterilizable Gel Breast Implant Sizer (Sizer) is a silicone elastomer device, filled with silicone gel, that is designed for temporary intraoperative 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.
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    K Number
    K010709
    Device Name
    MENTOR STERILE SALINE MAMMARY VOLUME SIZERS
    Manufacturer
    MENTOR CORP.
    Date Cleared
    2001-04-23

    (45 days)

    Product Code
    MRD
    Regulation Number
    N/A
    Why did this record match?
    Product Code :

    MRD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K984106
    Device Name
    MAMMARY SIZER, MAMMARY PROTHESIS SIZER
    Manufacturer
    SPECIALTY SURGICAL PRODUCTS, INC.
    Date Cleared
    1999-02-12

    (87 days)

    Product Code
    MRD
    Regulation Number
    N/A
    Why did this record match?
    Product Code :

    MRD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The mammary sizer is designed for single use, temporary intraoperative placement in a surgically created pocket. The sizer is used to evaluate the appropriate mammary prosthesis volume for each patient prior to implantation of a mammary prosthesis.
    Device Description
    Not Found
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