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

    120 FR OPTILUME PROSTATE BALLOON DILATOR

    K Number: K920551 · Decision Oct 28, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    68
    Registration Numbers
    68
    Same Product Code
    26
    Applicant Total
    72
    Review Days
    265

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    Basic Information

    Device Name
    120 FR OPTILUME PROSTATE BALLOON DILATOR
    K Number
    K920551
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5520
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    American Medical Systems, Inc.
    Date Received
    February 6, 1992
    Decision Date
    October 28, 1992
    Product Code
    KOE
    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
    KOE Dilator, Urethral

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