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

    ERCO-RIBBON -C

    K Number: K990008 · Decision Feb 24, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    49
    Registration Numbers
    49
    Same Product Code
    86
    Applicant Total
    6
    Review Days
    51

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    Basic Information

    Device Name
    ERCO-RIBBON -C
    K Number
    K990008
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5020
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ercons, Inc.
    Date Received
    January 4, 1999
    Decision Date
    February 24, 1999
    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 Ercons, Inc.

    K Number Device Name
    K990006 ERCO-VAC -C
    K981343 ERCO-RIBBON
    K981357 ERCO-VAC
    K972537 ERCO-VAC
    K972353 ERCO-RIBBON