BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    MENTOR ARIS SUPRAPUBIC SURGICAL KIT

    K Number: K053296 · Decision Dec 15, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28
    Same Product Code
    64
    Applicant Total
    4
    Review Days
    20

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    Basic Information

    Device Name
    MENTOR ARIS SUPRAPUBIC SURGICAL KIT
    K Number
    K053296
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.3300
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Mentor Corporation
    Date Received
    November 25, 2005
    Decision Date
    December 15, 2005
    Product Code
    OTN
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    OTN Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator

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    Other Clearances by Mentor Corporation

    K Number Device Name
    K062421 MENTOR RESTERILIZABLE GEL BREAST IMPLANT SIZER
    K052440 MENTOR SELF-CATH HYDROGEL INTERMITTENT CATHETER
    K050148 MENTOR ARIS TRANS-OBTURATOR TAPE AND SURGICAL KIT