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

    LIGASURE IMPACT CURVED, LARGE JAW, OPEN SEALER / DIVIDER

    K Number: K123444 · Decision Jan 30, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    823
    Registration Numbers
    823
    Same Product Code
    2306
    Applicant Total
    6
    Review Days
    83

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    Basic Information

    Device Name
    LIGASURE IMPACT CURVED, LARGE JAW, OPEN SEALER / DIVIDER
    K Number
    K123444
    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
    Covidien, Formerly Valleylab, A Division of Tyco H
    Date Received
    November 8, 2012
    Decision Date
    January 30, 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 Covidien, Formerly Valleylab, A Division of Tyco H

    K Number Device Name
    K141371 SONICISION CORDLESS ULTRASONIC DISSECTOR
    K133338 LIGASURE 5 MM MARYLAND JAW SEALER/DIVIDER ONE-STEP SEALING (LF 17XX)
    K131170 SONICISION STERILIZATION TRAY
    K113572 LIGASURE CURVED, SMALL JAW, OPEN SEALER/DIVIDER
    K102913 FORCETRIAD