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510(k) Data Aggregation
K Number
K212852Device Name
Areus(TM) Adapt Endoscopic Ultrasound Aspiration Needle, Tridemt(TM) Endoscopic Ultrasound Aspiration Needle
Manufacturer
Micro-Tech(Nanjing) Co., Ltd.
Date Cleared
2021-12-06
(90 days)
Product Code
ODG, FCG
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
Micro-Tech(Nanjing) Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The device is designed to sample targeted submucosal and extraluminal gastrointestinal lesions through the accessory channel of suitable ultrasound videoendoscope in adult patients only.
Device Description
The proposed Endoscopic Ultrasound Aspiration Needle is a sterile single-use device, designed to sample targeted submucosal and extraluminal gastrointestinal lesions through the accessory channel of suitable ultrasound videoendoscope. The Endoscopic Ultrasound Aspiration Needle consists of an Aspiration Needle and negative suction device. The proposed devices are EO sterilized to achieve the Sterility Assurance Level (SAL) of 10-6 and placed in a sterility maintenance package to ensure a shelf life of 2 years.
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