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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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    K Number
    K202299
    Device Name
    Ultrasonic Surgical Aspirator System
    Manufacturer
    SMTP Technology Co., Ltd
    Date Cleared
    2021-05-21

    (281 days)

    Product Code
    LFL
    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 XD880B Ultrasonic Surgical Aspirator System is an ultrasonic powered surgical tool. It can be used for precise breakage, aspiration and debridement of soft tissue, and can also be used for precise cutting, crushing and shaping of bone tissue. The product can be applied to a number of departments by using the suitable parameters and accessories, including: - . Department of Neurosurgery, general surgery and other departments for soft tissue cutting, 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 XD880B Ultrasonic Surgical Aspirator System consists of a console, foot switch, and accessories. The accessories include handpiece, tips, wrench, liquid-flow tube, sterilization tray, suction bag, suction canister and mobile cart. The handpiece, tips, liquid-flow tube are assembled into ultrasonic tool part to complete the cutting and fragment of bone tissue and soft tissues.
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    K Number
    K201274
    Device Name
    Ultrasonic Osteotomy Surgical System
    Manufacturer
    SMTP Technology Co., Ltd
    Date Cleared
    2021-02-19

    (283 days)

    Product Code
    JDX
    Regulation Number
    888.4580
    Why did this record match?
    Applicant Name (Manufacturer) :

    SMTP Technology Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Ultrasonic Osteotomy Surgical System is an ultrasonic surgical system consisting of a handpiece and associated tips for cutting bone, osteotomy, osteoplasty and drilling in a variety of surgical procedures, including but not limited to: - Otolaryngology - Oral/maxillofacial - Hand and foot - Neurosurgery - Spine - Plastic/reconstructive.
    Device Description
    Ultrasonic Osteotomy Surgical System uses ultrasonic technology to generate mechanical microvibrations of the tip insert connected to the handpiece, the piezoelectric transducer converting the electrical voltage supplied by the ultrasonic generator into mechanical energy that induces vibration of the tip insert at the resonant frequency of the cutting tip insert. The tips are used to fragment and reshape bone tissue through longitudinal vibration at high frequency and small amplitude. Ultrasonic Osteotomy Surgical System consists of a console (control unit) with an integrated peristaltic pump, a handpiece with a connecting cord, a range of cutting tips, wrench and torque wrench, a foot switch and irrigation set (liquid-flow tube and liquid-flow sleeve). The console has a color LCD touch screen user interface for the selection/visualization of device functional parameters. The console activates and controls the ultrasound vibration, controls irrigation flow and displays system condition. The console is connected to the main power by an electrical cord. It includes connectors for the handpiece and for the footswitch. The console incorporates a peristaltic pump which provides, through the irrigation tubing set, a sterile fluid supply to the surgical site. Ultrasonic power and irrigation flow to the handpiece are simultaneously activated by pressing the footswitch. The handpiece contains a piezoelectric ultrasonic transducer which attaches to the generator (inside the console) by a cable at one end of the handpiece. Tip inserts are attached to the other end of the handpiece.
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