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

    LIGASURE 5MM BLUNT TIP LAPAROSCOPIC SEALER-DIVIDER

    K Number: K092879 · Decision Oct 16, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    823
    Registration Numbers
    823
    Same Product Code
    2306
    Applicant Total
    10
    Review Days
    28

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    Basic Information

    Device Name
    LIGASURE 5MM BLUNT TIP LAPAROSCOPIC SEALER-DIVIDER
    K Number
    K092879
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    878.4400
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Valleylab
    Date Received
    September 18, 2009
    Decision Date
    October 16, 2009
    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 Valleylab

    K Number Device Name
    K063195 LIGASURE ADVANCE LAPAROSCOPIC SEALER/DIVIDER WITH DISSECTING ELECTRODE, MODELS LF5034 AND LF5044
    K053535 VIVAWAVE MICROWAVE ABLATION SYSTEM
    K053290 COOL-TIP RF GENERATOR, COOL-TIP RF SYSTEM ACCESSORIES
    K052796 COOL-TIP RF GENERATOR, COOL-TIP RF SYSTEM ACCESSORIES
    K051644 VALLEYLAB FORCETRIAD ELECTROSURGICAL GENERATOR
    K051627 VALLEYLAB G3000 ELECTROSURGICAL INSTRUMENT
    K043273 LIGASURE VESSEL SEALING SYSTEM. LIGASURE INSTRUMENTS
    K042216 COOL-TIP RF ABLATION SYSTEM
    K041587 LIGASURE PRECISE MODEL #LS1200/LIGASURE 5MM LAPAROSCOPIC SEALER DIVIDER MODEL # LS1500