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

    MODEL P8400 HEMOSTATIX THERMAL SCALPEL SYSTEM

    K Number: K091107 · Decision May 1, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    823
    Registration Numbers
    823
    Same Product Code
    2306
    Applicant Total
    2
    Review Days
    15

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    Basic Information

    Device Name
    MODEL P8400 HEMOSTATIX THERMAL SCALPEL SYSTEM
    K Number
    K091107
    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
    Hemostatix Medical Technologies, LLC
    Date Received
    April 16, 2009
    Decision Date
    May 1, 2009
    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 Hemostatix Medical Technologies, LLC

    K Number Device Name
    K183009 HEMOSTATIX MODEL P8400 DISPOSABLE HANDLE, HEMOSTATIX MODEL P8400 DISPOSABLE BLADES