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510(k) Data Aggregation

    K Number
    K212750
    Device Name
    Ultrasonic Surgical Aspirator System, Model: XD880B
    Manufacturer
    SMTP Technology Co., Ltd.
    Date Cleared
    2021-09-27

    (28 days)

    Product Code
    LFL, CLA
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    SMTP Technology Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The XD880B Ultrasonic Surgical Aspirator System is an ultrasonic surgical system consisting of handpieces and associated tips. The product is intended for the fragmentation, emulsification of both soft and hard (i.e. bone and bone approximations) tissue, the intended use is as follows with different configurations: - · Neurosurgery - · Gastrointestinal and Affiliated Organ Surgery - · Urological surgery - · Plastic and Reconstructive surgery - · General Surgery - · Orthopedic Surgery - · Gynecological Surgery - · Thoracic Surgery - · Wound Care - · Laparoscopic Surgery - · Thoracoscopic Surgery
    Device Description
    The Ultrasonic Surgical Aspirator System (Model: XD880B) is an ultrasonic powered surgical tool. It can be used for precise breakage, aspiration and debridement of soft tissues, and can also be used for precise cutting and shaping of bone tissue, using with the liguid-flow sleeve and liquid-flow tube. The product can be applied to a number of departments according to the suitable parameters and accessories, including: - . Department of Neurosurgery, general surgery and other departments for soft tissue breakage and aspiration. - Department of Orthopedic surgery, Plastic and Reconstructive surgery, Department of Neurosurgery (only for bone) for bone cutting. - . As well as the Department of Dermatology, Department of Trauma Orthopedics and other departments used for debridement. The Ultrasonic Surgical Aspirator System consists of a console, application software, foot switch, and accessories. The accessories include handpieces, tips, wrenches, liquid-flow sleeves, liquid-flow tubes, sterilization tray, suction canister and mobile cart. The handpiece, tip, liquid-flow sleeve and liquid-flow tube assemble to ultrasonic tool part to complete the cutting and fragment of soft tissue and bone tissue.
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