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

    NEEDLELESS SLING

    K Number: K063136 · Decision Dec 19, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    15
    Registration Numbers
    15
    Same Product Code
    19
    Applicant Total
    3
    Review Days
    64

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    Basic Information

    Device Name
    NEEDLELESS SLING
    K Number
    K063136
    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
    Specialities Remeex International, S.L.
    Date Received
    October 16, 2006
    Decision Date
    December 19, 2006
    Product Code
    PAH
    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
    PAH Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-Sling

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    Other Clearances by Specialities Remeex International, S.L.

    K Number Device Name
    K062341 MALE REMEEX SYSTEM
    K033310 REMEEX SYSTEM FOR URINARY INCONTINENCE