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

    VACURECT VACUUM CONSTRICTION DEVICE

    K Number: K020969 · Decision Jun 5, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    49
    Registration Numbers
    49
    Same Product Code
    86
    Applicant Total
    2
    Review Days
    71

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    Basic Information

    Device Name
    VACURECT VACUUM CONSTRICTION DEVICE
    K Number
    K020969
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5020
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Vacurect Manufacturing (Pty) , Ltd.
    Date Received
    March 26, 2002
    Decision Date
    June 5, 2002
    Product Code
    LKY
    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
    LKY Device, External Penile Rigidity

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    Other Clearances by Vacurect Manufacturing (Pty) , Ltd.

    K Number Device Name
    K032776 VACURECT VACUUM CONSTRICTION DEVICE