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

    INTUBATION ENDOSCOPE AND INTRODUCER SHEATH

    K Number: K970107 · Decision Nov 18, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    163
    Registration Numbers
    163
    Same Product Code
    238
    Applicant Total
    3
    Review Days
    309

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    Basic Information

    Device Name
    INTUBATION ENDOSCOPE AND INTRODUCER SHEATH
    K Number
    K970107
    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
    Urohealth Systems, Inc.
    Date Received
    January 13, 1997
    Decision Date
    November 18, 1997
    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 Urohealth Systems, Inc.

    K Number Device Name
    K980617 MODIFICATION TO REFLEX AEC LINEAR STAPLER/CUTTER
    K972510 PIVOTAL SCISSOR