BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇦 Canada

    O'REGAN LIGATOR

    K Number: K963166 · Decision May 5, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    87
    Registration Numbers
    87
    Same Product Code
    21
    Applicant Total
    1
    Review Days
    264

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    Basic Information

    Device Name
    O'REGAN LIGATOR
    K Number
    K963166
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.4400
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Patrick J. O'Regan
    Date Received
    August 14, 1996
    Decision Date
    May 5, 1997
    Product Code
    FHN
    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
    FHN Ligator, Hemorrhoidal

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