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

    HABIB ENDOHPB

    K Number: K083292 · Decision Jun 10, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    117
    Registration Numbers
    117
    Same Product Code
    187
    Applicant Total
    10
    Review Days
    212

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    Basic Information

    Device Name
    HABIB ENDOHPB
    K Number
    K083292
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.4300
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Emcision , Ltd.
    Date Received
    November 10, 2008
    Decision Date
    June 10, 2009
    Product Code
    KNS
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    Y

    Classifications

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

    Product Code Device Name
    KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories)

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    Other Clearances by Emcision , Ltd.

    K Number Device Name
    K180165 Habib EndoHPB
    K161305 Habib EUS RFA
    K150029 Habib EUS RFA
    K080717 HABIB HEXABLATE 10
    K073687 HABIB LAPAROSCOPIC HEXABLATE
    K072383 HABIB ENDOBLATE
    K072126 HABIB VESEAL
    K071103 HABIB HEXABLATE
    K051420 HABIB 4X