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510(k) Data Aggregation

    K Number
    K171956
    Device Name
    Sterile Endoscope Biopsy Sampling Needle
    Date Cleared
    2017-12-12

    (166 days)

    Product Code
    Regulation Number
    876.1075
    Why did this record match?
    Applicant Name (Manufacturer) :

    Changzhou Detain Medical Devices Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Sterile endoscope biopsy sampling need to sample targeted submucosal and extramural lesions within or adjacent to the tracheobronchial tree or gastrointestinal tract through the accessory channel of an ultrasound endoscope.
    Device Description
    Sterile endoscope biopsy sampling needle, Model: DT-EN-W7 is mainly composed of needle head, PEEK outer tube assembly, and handle. Sizes are available in 18 - 22 gauge needles. The length of the needles range is between 0 and 80 mm. The needle is used by advancing the entire device to the site of soft tissue sampling through endoscopic channel aperture. The needle is advanced with gentle but firm pressure. Once the needle is in position, stab hard into the tissue and connect the external end of needle tube with aspirator in negative pressure. Retreat the needle head into tube, and get the needle out of the endoscope through the channel. The sample can then be expelled from the stylet notch.
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