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510(k) Data Aggregation

    K Number
    K030890
    Device Name
    SWITCHBLADE
    Manufacturer
    SNOWDEN PENCER, INC.
    Date Cleared
    2003-04-04

    (14 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    SNOWDEN PENCER, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Switch-Blade® disposable scissor tips are supplied sterile and are intended for single use. The disposable scissor tips in conjunction with the reusable scissor shaft are intended to be connected to an Electrosurgical Unit via cables to allow high frequency monopolar cutting and coagulation of tissue.
    Device Description
    The Switch-Blade® scissor tip product family consists of three configurations differing only in size and shape. The Switch-Blade® is supplied sterile in an individual Tyvek® pouch; six of these pouches are placed in 6 unit box (i.e. sales unit). The product is intended to be single use and is used in conjunction with catalog numbers 90-1050, 90-1150 or 90-1250 to achieve electrosurgical cutting and coagulation of tissue. The device consists of metal and polymer components.
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