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

    MENTOR RESTERILIZABLE GEL BREAST IMPLANT SIZER

    K Number: K062421 · Decision Oct 10, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    12
    Applicant Total
    4
    Review Days
    53

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    Basic Information

    Device Name
    MENTOR RESTERILIZABLE GEL BREAST IMPLANT SIZER
    K Number
    K062421
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Mentor Corporation
    Date Received
    August 18, 2006
    Decision Date
    October 10, 2006
    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.

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    MENTOR™ MemoryGel™ Enhance Single Use Gel Sizer

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    NATRELLE INSPIRA Single Use Sizers for Gel Implants

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    Sientra OPUS Silicone Gel Breast Implant Sizer

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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 Corporation

    K Number Device Name
    K053296 MENTOR ARIS SUPRAPUBIC SURGICAL KIT
    K052440 MENTOR SELF-CATH HYDROGEL INTERMITTENT CATHETER
    K050148 MENTOR ARIS TRANS-OBTURATOR TAPE AND SURGICAL KIT