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

    KARL STORZ CUTTING LOOP ELECTRODES MODIFICATION

    K Number: K934647 · Decision Feb 9, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    41
    Registration Numbers
    41
    Same Product Code
    23
    Applicant Total
    318
    Review Days
    133

    Basic Information

    Device Name
    KARL STORZ CUTTING LOOP ELECTRODES MODIFICATION
    K Number
    K934647
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    KARL STORZ ENDOSCOPY-AMERICA, INC.
    Date Received
    September 29, 1993
    Decision Date
    February 9, 1994
    Product Code
    FJL
    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
    FJL Resectoscope

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    Other Clearances by KARL STORZ ENDOSCOPY-AMERICA, INC.

    K Number Device Name
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    K143640 KSEA CMOS Camera System (C-cam)
    K142556 Flexible Video-Uretero-Choledochoscope System
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