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

    KARL STORZ HUZLY HIGH-FREQUENCY CUTTING LOOPS

    K Number: K960791 · Decision Mar 11, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    163
    Registration Numbers
    163
    Same Product Code
    238
    Applicant Total
    334
    Review Days
    13

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    Basic Information

    Device Name
    KARL STORZ HUZLY HIGH-FREQUENCY CUTTING LOOPS
    K Number
    K960791
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.4680
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    KARL STORZ Endoscopy-America, Inc.
    Date Received
    February 27, 1996
    Decision Date
    March 11, 1996
    Product Code
    EOQ
    Advisory Committee
    Ear, Nose, Throat
    Review Advisory Committee
    EN
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    EOQ Bronchoscope (Flexible Or Rigid)

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    Other Clearances by KARL STORZ Endoscopy-America, Inc.

    K Number Device Name
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    K201135 Image1 S CCU, Image1 S 4U Camera Head
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    K191357 Flexible HD Cysto-Urethroscope System
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