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510(k) Data Aggregation

    K Number
    K241367
    Device Name
    RF Cannula
    Manufacturer
    Shanghai SAMedical & Plastic Instruments Co., Ltd.
    Date Cleared
    2025-01-23

    (254 days)

    Product Code
    GXI
    Regulation Number
    882.4725
    Type
    Traditional
    Panel
    Neurology
    Reference & Predicate Devices
    K112231
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The RF cannula is intended for use in RF heat lesion procedures for the relief of pain.

    Device Description

    The RF Cannula is composed of Cannula, Cannula hub, Stylet, Stylet hub, Insulating layer, Depth stop and Protection tube.

    Materials being used include SUS 304 stainless steel, K-Resin, polyethylene, polyethylene terephthalate.

    RF Cannula is supplied sterile and is only for single-use. It is used in conjunction with a RF Generator and RF Electrode and other accessories to create Radiofrequency (RF) Lesions of nerve tissue or for use in percutaneous nerve blocks. During the RF heat lesion procedure, the RF cannula bare tip is placed into the target tissue; preloaded stylet is withdrawn and replaced by the RF Electrode. The radio frequency is produced by the RF Generator and released by the cannula bare tip.

    AI/ML Overview

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