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510(k) Data Aggregation

    K Number
    K182675
    Device Name
    Polygon Resection Device
    Date Cleared
    2019-01-04

    (100 days)

    Product Code
    Regulation Number
    884.1690
    Why did this record match?
    Applicant Name (Manufacturer) :

    Polygon Medical, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Polygon Resection Device is intended for intrauterine use by a trained gynecologist to hysteroscopically resect and remove tissue, including focal lesions such as endometrial polyps and retained products of conception.
    Device Description
    The Polygon Resection Device is a handheld manually operated device designed for the hysteroscopic removal of intrauterine tissue. The device is provided sterile. The shaft of the device is design to fit into the working channel of any hysteroscope that includes a 3.0 mm (Fr) straight working channel. The device is activated by the physician by squeezing the trigger. A rotation knob is provided to enable the physician to rotate the cutting bay into an orientation that aligns with the desired specimen. The barb fitting provides an attachment port for a vacuum system. The vacuum system pulls the specimen into the cutting window where it can be resected and aspirated out of the patient. There are no electrical or powered connections necessary for operation of the device.
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