BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇬🇧 United Kingdom

    HABIB HEXABLATE 10

    K Number: K080717 · Decision Mar 27, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    823
    Registration Numbers
    823
    Same Product Code
    2306
    Applicant Total
    10
    Review Days
    14

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    Basic Information

    Device Name
    HABIB HEXABLATE 10
    K Number
    K080717
    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
    Emcision , Ltd.
    Date Received
    March 13, 2008
    Decision Date
    March 27, 2008
    Product Code
    GEI
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    Y

    Classifications

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

    Product Code Device Name
    GEI Electrosurgical, Cutting & Coagulation & Accessories

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    Other Clearances by Emcision , Ltd.

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    K073687 HABIB LAPAROSCOPIC HEXABLATE
    K072383 HABIB ENDOBLATE
    K072126 HABIB VESEAL
    K071103 HABIB HEXABLATE
    K051420 HABIB 4X