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

    DISTENDING DIVERTICULOSCOPE

    K Number: K953596 · Decision Sep 26, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    163
    Registration Numbers
    163
    Same Product Code
    238
    Applicant Total
    334
    Review Days
    56

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    Basic Information

    Device Name
    DISTENDING DIVERTICULOSCOPE
    K Number
    K953596
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.4680
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    KARL STORZ Endoscopy-America, Inc.
    Date Received
    August 1, 1995
    Decision Date
    September 26, 1995
    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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    K191357 Flexible HD Cysto-Urethroscope System
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