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510(k) Data Aggregation

    K Number
    K972311
    Device Name
    MODEL 20 BIPOLAR COAGULATOR
    Manufacturer
    BOSTON SURGICAL PRODUCTS, INC.
    Date Cleared
    1997-09-18

    (90 days)

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

    BOSTON SURGICAL PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Boston Surgical Products, Inc. Model 20 Coagulation Generator is a solid state bipolar generator to supply the RF signal to electrosurgical handpieces used on soft body tissues where low impedance or wetfield conditions exist.
    Device Description
    The handswitch is powered by an independent low voltage (7 Vdc) isolated power supply. Audio and Visual monitors are in accord with IEC 601-1-2 and ANSI HF-18 guidelines. RF and Low Frequency leakages are well within IEC 601-1-2 and ANSI HF-18 safety guide lines for isolated (body floating) bipolar coagulators. This device is technically identical to an existing approved device (Kirwan Model 25 1000, 510k K880863) but repackaged in e new style enclosure and relabeled Boston Surgical Products Model 20.
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    K Number
    K972350
    Device Name
    MODEL 50 BIPOLAR COAGULATOR
    Manufacturer
    BOSTON SURGICAL PRODUCTS, INC.
    Date Cleared
    1997-08-21

    (58 days)

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

    BOSTON SURGICAL PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Boston Surgical Products, Inc. Model 50 Coagulator General purposes solid state bipolar generator to supply the RF signal to electrosurycal handpieces used to coagulate soft body tissues where a wide range of tissue types, patient conditions, and load impediances are encountered.
    Device Description
    A 0-50 digital display power setting indicator provides the operator a parallax free reading of the power setting (+/- Swatts, full scale (@ 100 ohms). A bar graph display output current monitor provides the operator a relative measure of the output current amplitude and to denote the presence of output energy during activation. The handswitch is powered by an independent low voltage (7 Vdc) isolated power supply. Audio and Visual monitors are in accord with IEC 601-1-2 and ANSI HF-18 guidelines. RF and Low Frequency leakages are well within IEC 601-1-2 and ANSI HF-18 safety guide lines for isolated (body floating) bipolar coagulators. This device is identical to an existing approved device.
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