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510(k) Data Aggregation

    K Number
    K232825
    Device Name
    Disposable Sphincterotome
    Manufacturer
    Jiangsu Vedkang Medical Science and Technology Co., Ltd.
    Date Cleared
    2024-03-29

    (198 days)

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

    Jiangsu Vedkang Medical Science and Technology Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K232752
    Device Name
    Stone Extraction Balloon (VDK-BAL-23-11/13/15-B,VDK-BAL-23-15/18/20-B,VDK-BAL-23-9/12/15-B,VDK-BAL-23-10/13/16-B,VDK-BAL-23-8.5/11.5/15-B,VDK-BAL-23-12/15/18-B,VDK-BAL-23-11/13/15-C,VDK-BAL-23-15/18/20-C,VDK-BAL-23-9/12/15-C,VDK-BAL-23-10/13/16-C,VDK-BAL-23-8.5/11.5/15-C,VDK-BAL-23-12/15/18-C)
    Manufacturer
    Jiangsu Vedkang Medical Science and Technology Co., Ltd.
    Date Cleared
    2024-02-26

    (171 days)

    Product Code
    GCA
    Regulation Number
    876.5010
    Why did this record match?
    Applicant Name (Manufacturer) :

    Jiangsu Vedkang Medical Science and Technology Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is intended for endoscopic removal of biliary stones. The device is supplied sterile and intended for single use only.
    Device Description
    Stone Extraction Balloon is composed of balloon, radiopaque marker, catheter, handle, standard connector, two-way valve, support wire and inflators. Stone Extraction Balloon is operated by the inflation and deflation of balloon, as well as liquid is injection port to assist in imaging or flushing, and complete the removal of biliary calculus the endoscopic channel. The Stone Extraction Balloon is classified to different specifications according to the diameter of balloon and the liquid outlet. There are a total of 12 models, the largest balloon diameter is 20mm, the smallest balloon diameter is only 8.5mm, the operator can choose according to different clinical needs. EO sterilization and use for single use only.
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    K Number
    K232245
    Device Name
    VedDilator ^TM (3-Stage Balloon Dilation Catheter)
    Manufacturer
    Jiangsu Vedkang Medical Science and Technology Co., Ltd.
    Date Cleared
    2024-02-15

    (202 days)

    Product Code
    FGE, KNO, KNQ
    Regulation Number
    876.5010
    Why did this record match?
    Applicant Name (Manufacturer) :

    Jiangsu Vedkang Medical Science and Technology Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    It is indicated for use in adult and adolescent populations to endoscopically dilate strictures of the alimentary tract.
    Device Description
    The 3-Stage Balloon Dilation Catheter can provide 3 different sizes and gradually increasing diameters through controlled radial expansion. The specific balloon size is printed on the label of each package and catheter. The 3-Stage Balloon Dilation Catheter is designed to pass through the working channel of the endoscope, and its guidewire cavity can accommodate a 0.035inches (0.89mm diameter) guidewire. In the package, a 0.035inches (0.89mm diameter) guidewire is pre-installed in the guidewire cavity. There is a guidewire locking device connected to the guide wire hole of the catheter. The locking device will be in the "OFF" (closed) position when it leaves the factory. Only when the switch of the locking device is in the "ON" position can it be pushed or moved forward. The guide wire is removed from the catheter. After turning the switch to the "OFF" position, the guide wire will be fixed in the catheter.
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    K Number
    K222146
    Device Name
    Disposable Endoscopic Hemoclip
    Manufacturer
    Jiangsu Vedkang Medical Science and Technology Co., Ltd.
    Date Cleared
    2023-03-28

    (251 days)

    Product Code
    PKL
    Regulation Number
    876.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    Jiangsu Vedkang Medical Science and Technology Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    It is indicated for Endoscopic clip placement within the Gastromtestinal tract in adult patients only via a straight or side viewing flexible endoscope for the purpose of: (1) Endoscopic marking (2) Hemostasis for (a) Mucosal/ sub-mucosal defects < 3cm (b)Bleeding ulcers. (c)Polyps<1.5cm in diameter, (d)Diverticula in the colon (e)Arteries <2 mm (f) Prophylactic clipping to reduce the risk of delayed bleeding post lesion resection; (3) As a supplementary method, closure of GI tract luminal perforations <20mm that can be treated conservatively
    Device Description
    The proposed device is a sterile, single-use endoscopic clipping device. It is consisted of two main components: the delivery system and the clip. The delivery system include: metal cap, spring sheath, pulling wire component, coating layer, protective tube, core rod, and slider. The clip include: clip components and sleeve, and it is deployed from the delivery system during use. The hemoclip can be opened and closed up to five times prior to deployment, aiding in repositioning of the clip at the lesion site. The device is available in four clip opening widths, which are 9mm, 11mm, and the device effective length is available in 1600mm, 1800mm, 2600mm, 2600mm.
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