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

    PENN & OLYMPUS URETEROSCOPY GUIDE SHEATH & DILATOR

    K Number: K862107 · Decision Sep 11, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    80
    Registration Numbers
    80
    Same Product Code
    71
    Applicant Total
    8
    Review Days
    100

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    Basic Information

    Device Name
    PENN & OLYMPUS URETEROSCOPY GUIDE SHEATH & DILATOR
    K Number
    K862107
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Penn Medical Devices, Inc.
    Date Received
    June 3, 1986
    Decision Date
    September 11, 1986
    Product Code
    ODC
    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
    ODC Endoscope Channel Accessory

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