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510(k) Data Aggregation

    K Number
    K150316
    Device Name
    Polypectomy Snare
    Date Cleared
    2015-07-30

    (171 days)

    Product Code
    Regulation Number
    876.4300
    Why did this record match?
    Applicant Name (Manufacturer) :

    MICRO- TECH (NANJING) CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Polypectomy Snares are used endoscopically in the removal of diminutive polyps, and pedunculated polyps within the GI tract.
    Device Description
    The proposed device Polypectomy Snare is a sterile, single-use endoscopic device, intended to be used endoscopically in the removal diminutive polyps, sessile polyps, and pedunculated polyps from within the GI tract. The Polypectomy Snares consists of a flexible wire cable and loop which can be extended and retracted from the snare's flexible outer sheath using a handle. When passed through an endoscope the snare can be activated to deliver a monopolar electrical current to cut and cauterize tissue with the loop. The proposed device has eighteen (18) specifications; the main differences of these specifications are dimension and if the loop can be rotatable with the rotation of the handle.
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