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

    ESTECH COBRA ADHERE XL 2 SURGICAL SYSTEM

    K Number: K113475 · Decision Mar 20, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    30
    Registration Numbers
    30
    Same Product Code
    52
    Applicant Total
    5
    Review Days
    119

    Basic Information

    Device Name
    ESTECH COBRA ADHERE XL 2 SURGICAL SYSTEM
    K Number
    K113475
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4400
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    ENDOSCOPIC TECHNOLOGIES, INC. D/B/A ESTECH
    Date Received
    November 22, 2011
    Decision Date
    March 20, 2012
    Product Code
    OCL
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

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

    Product Code Device Name
    OCL Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue

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    Other Clearances by ENDOSCOPIC TECHNOLOGIES, INC. D/B/A ESTECH

    K Number Device Name
    K110913 ESTECH COBRA SURGICAL SYSTEM WITH THERMASHIELD ACCESSORY
    K100224 ESTECH COBRA BIPOLSR II
    K091542 ESTECH EASYFLOW CANNULA WITH GUIDEWIRE
    K091350 ESTECH HAWKEYE INTRODUCER SYSTEMS