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510(k) Data Aggregation
K Number
K171956Device Name
Sterile Endoscope Biopsy Sampling Needle
Manufacturer
Date Cleared
2017-12-12
(166 days)
Product Code
Regulation Number
876.1075Why 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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