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

    ESTECH HAWKEYE INTRODUCER SYSTEMS

    K Number: K091350 · Decision Sep 15, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    548
    Registration Numbers
    548
    Same Product Code
    1422
    Applicant Total
    5
    Review Days
    131

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    Basic Information

    Device Name
    ESTECH HAWKEYE INTRODUCER SYSTEMS
    K Number
    K091350
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Endoscopic Technologies, Inc. D/B/A Estech
    Date Received
    May 7, 2009
    Decision Date
    September 15, 2009
    Product Code
    GCJ
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    GCJ Laparoscope, General & Plastic Surgery

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    Other Clearances by Endoscopic Technologies, Inc. D/B/A Estech

    K Number Device Name
    K113475 ESTECH COBRA ADHERE XL 2 SURGICAL SYSTEM
    K110913 ESTECH COBRA SURGICAL SYSTEM WITH THERMASHIELD ACCESSORY
    K100224 ESTECH COBRA BIPOLSR II
    K091542 ESTECH EASYFLOW CANNULA WITH GUIDEWIRE