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510(k) Data Aggregation

    K Number
    K230598
    Device Name
    Stone Extraction Baskets
    Manufacturer
    Jiangsu Vedkang Medical Science and TechnologyCo.,Ltd
    Date Cleared
    2023-09-12

    (193 days)

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

    Jiangsu Vedkang Medical Science and TechnologyCo.,Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Endoscopic removal of stones in the biliary system and foreign bodies.
    Device Description
    The Stone Extraction Baskets is a sterile, single use device compatible with the accessory channel of endoscopes (Minimum Endoscope Channel Inner Diameter: 2mm and 2.8mm). Diameters of Outer Tube of the device are 1.8mm and 2.3mm, working lengths are 700mm,200mm and 2300mm, and open widths are 10mm, 15mm, 20mm,35mm,40mm, and the devices have eight types of baskets and two kinds of handles (single hand type and two hands type). It is comprised of guiding head (stainless steel/nitinol), pulling wire (stainless steel), outer tube(PTFE) and handle components (ABS, stainless steel and etc.). Basket is advanced out of and retracted into the polytetrafluoroethylene outer tube using the handle. The device is not compatible with any mechanical lithotripter.
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