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510(k) Data Aggregation

    K Number
    K022989
    Device Name
    RADLITE TISSUE RETRACTOR SYSTEM
    Manufacturer
    GENZYME BIOSURGERY
    Date Cleared
    2002-11-25

    (77 days)

    Product Code
    FSW
    Regulation Number
    878.4580
    Why did this record match?
    Product Code :

    FSW

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Tissue Retractor System is intended for use in dissecting and retracting in all types of surgical procedures requiring dissection and retraction of tissue. The RadLite™ Tissue Retractor System has application for the creation and maintenance of an operative cavity in the extraperitoneal spaces such as the retroperitoneal, preperitoneal and subcutaneous areas. The device may be used in all types of surgical procedures requiring retraction of tissue.
    Device Description
    The Genzyme Tissue Retractor System s is a surgical instrument that provides a means to create and maintain a cavity by retracting the subcutaneous layer to expose the conduit. The retraction is sufficient to allow enough exposure to dissect and retract subcutaneous tissue for performing all types of surgical procedures. This system consists of the following components: - Handle: The handle securely holds the retractor blade, light panel, and provides a host adaptor for ACMI connection to a variety of commercially available light sources. - Retractor/blade: The stainless steel retractor blade attaches to the handle for lifting the subcutaneous layer. - Fiber Optic Light Panel: The light panel fits securely into the handle on the underside of the retractor blade to provide illumination for the procedure.
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    K Number
    K013511
    Device Name
    XENALIGHT MODELS # AX9125 (100-120V~); # AX9225 (220-240V~)
    Manufacturer
    ACULUX, INC.
    Date Cleared
    2002-02-01

    (102 days)

    Product Code
    FSW
    Regulation Number
    878.4580
    Why did this record match?
    Product Code :

    FSW

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The XenaLight™ Fiberoptic Illuminator, also known as a lightsource, is attached to a fiberoptic cable transmitting the light to a fiberoptic headlamp, retractor, endoscopic instrument, etc, providing light to the surgical operating field. This light is utilized in many different surgical procedures requiring additional light when overhead lighting is not sufficient.
    Device Description
    The XenaLight™ Fiberoptic Illuminator, also known as a lightsource, is attached to a fiberoptic cable transmitting the light to a fiberoptic headlamp, retractor, endoscopic instrument, etc, providing light to the surgical operating field. This light is utilized in many different surgical procedures requiring additional light when overhead lighting is not sufficient. The fiberoptic cable and/or headlamps are an accessory to the XenaLight™ Fiberoptic Illuminator to transmit the light from the lightsource.
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