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

    CATHEJELL S STERILE LUBRICATING JELLY

    K Number: K935548 · Decision Mar 30, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    5
    Applicant Total
    1
    Review Days
    133

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    Basic Information

    Device Name
    CATHEJELL S STERILE LUBRICATING JELLY
    K Number
    K935548
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Pharmazeutische Fabrik Montavit GmbH
    Date Received
    November 17, 1993
    Decision Date
    March 30, 1994
    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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