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

    KARL STORZ 27086KC ULTRASONIC LITHOTRI

    K Number: K843101 · Decision Dec 11, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    21
    Registration Numbers
    21
    Same Product Code
    13
    Applicant Total
    334
    Review Days
    126

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    Basic Information

    Device Name
    KARL STORZ 27086KC ULTRASONIC LITHOTRI
    K Number
    K843101
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.4480
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    KARL STORZ Endoscopy-America, Inc.
    Date Received
    August 7, 1984
    Decision Date
    December 11, 1984
    Product Code
    FEO
    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
    FEO Lithotriptor, Ultrasonic

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    Other Clearances by KARL STORZ Endoscopy-America, Inc.

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    K201135 Image1 S CCU, Image1 S 4U Camera Head
    K200740 HD Video Rhino Laryngoscope
    K191357 Flexible HD Cysto-Urethroscope System
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