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

    PEAK PLASMABLADE 3.OS TISSUE DISSECTION DEVICE

    K Number: K093695 · Decision Apr 13, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    823
    Registration Numbers
    823
    Same Product Code
    2306
    Applicant Total
    7
    Review Days
    134

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    Basic Information

    Device Name
    PEAK PLASMABLADE 3.OS TISSUE DISSECTION DEVICE
    K Number
    K093695
    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
    Peak Surgical, Inc.
    Date Received
    November 30, 2009
    Decision Date
    April 13, 2010
    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 Peak Surgical, Inc.

    K Number Device Name
    K103775 PEAK SUCTION COAGULATOR
    K102709 PEAK PLASMABLADE PLUS TISSUE DISSECTION DEVICE
    K102029 PEAK PULSAR II GENERATOR MODEL PS100-102
    K083415 PEAK PLASMABLADE TNA TONSIL AND ADENOID TISSUE DISSECTION DEVICE
    K082786 PULSAR GENERATOR, PEAK PLASMABLADE; 4.0, NEEDLE, AND EXT TISSUE DISSECTION DEVICES
    K073057 PULSAR GENERATOR, MODEL PS100-100, AND PEAK PLASMABLADE TISSUE DISSECTION DEVICE, MODEL PS200-040