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

    K-Y Marilyn Pleasure Gel

    K Number: K151884 · Decision Jan 11, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    123
    Registration Numbers
    123
    Same Product Code
    242
    Applicant Total
    5
    Review Days
    186

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    Basic Information

    Device Name
    K-Y Marilyn Pleasure Gel
    K Number
    K151884
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.5300
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Reckitt Benckiser, LLC
    Date Received
    July 9, 2015
    Decision Date
    January 11, 2016
    Product Code
    NUC
    Advisory Committee
    Obstetrics/Gynecology
    Review Advisory Committee
    OB
    Third Party
    N

    Classifications

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

    Product Code Device Name
    NUC Lubricant, Personal

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    Other Clearances by Reckitt Benckiser, LLC

    K Number Device Name
    K173504 K-Y Silicone
    K143532 Durex Silicone
    K131643 DUREX REALFEEL PLEASURE GEL PERSONAL LUBRICANT
    K140193 DUREX EMBRACE PERSONAL LUBRICANT