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510(k) Data Aggregation

    K Number
    K151714
    Device Name
    Disposable Endoscope Valves Set A
    Date Cleared
    2015-12-03

    (161 days)

    Product Code
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    WILSON INSTRUMENTS (SHANGHAI) COMPANY LIMITED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    A collection of sterile device intended to be fitted to multiple endoscope working channels/ports to enable anoscope operator control the function of the working channels/ports and prevent retrograde flow of fluids, gases, and other materials. It typically includes a suction valve, an air/water valve, and a biopsy valve. This is a single-use device.
    Device Description
    Wilson's Disposable Endoscope Valves Set A collects three types of valve products into one package unit. Disposable Endoscope Valves Set A can make it convenient for the replacement of Air/Water Valves, Suction Valves, Biopsy Valve during an endoscopic procedure. And these three types' valves can realize their intended uses respectively.
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    K Number
    K142144
    Device Name
    DISPOSABLE INJECTION NEEDLE
    Date Cleared
    2015-01-15

    (163 days)

    Product Code
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    WILSON INSTRUMENTS (SHANGHAI) COMPANY LIMITED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Wilson disposable injection needle has been designed to be used with an endoscope to perform following therapy: 1. Endoscopic sclerotherapy within the esophagus, stomach, duodenum, small intestine, large intestine. 2. Endoscopic hemostasis within the esophagus, stomach, duodenum, small intestine, large intestine. 3. Endoscopic submucosal injection within esophagus, stomach, duodenum, small intestine, large intestine.
    Device Description
    The subjected Disposable Injection Needle is operated together with an endoscope to conduct an endoscopic injection for the treatment of esophageal and gastric varices and submucosal injection in the digestive tract, such as esophagus, stomach, duodenum, small intestine, large intestine. The subjected device is primarily constituted of handle, tube and needle. The models include PN series, PM series and PM(H) series.
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