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

    K-Y LUBRICATING JELLY

    K Number: K780386 · Decision Apr 13, 1978
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    5
    Applicant Total
    206
    Review Days
    34

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    Basic Information

    Device Name
    K-Y LUBRICATING JELLY
    K Number
    K780386
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Johnson & Johnson Professionals, Inc.
    Date Received
    March 10, 1978
    Decision Date
    April 13, 1978
    Product Code
    FHX
    Advisory Committee
    Gastroenterology, Urology
    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
    FHX Jelly, Lubricating, For Transurethral Surgical Instrument

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