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

    THE JUSTRIGHT SURGICAL VESSEL SEALING SYSTEM

    K Number: K123662 · Decision May 22, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    823
    Registration Numbers
    823
    Same Product Code
    2306
    Applicant Total
    2
    Review Days
    175

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    Basic Information

    Device Name
    THE JUSTRIGHT SURGICAL VESSEL SEALING SYSTEM
    K Number
    K123662
    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
    Justright Surgical, LLC
    Date Received
    November 28, 2012
    Decision Date
    May 22, 2013
    Product Code
    GEI
    Advisory Committee
    General, Plastic Surgery
    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
    GEI Electrosurgical, Cutting & Coagulation & Accessories

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    Other Clearances by Justright Surgical, LLC

    K Number Device Name
    K132472 JUSTRIGHT 5MM STAPLER, JUSTRIGHT 5MM RELOAD