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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscopic Ultrasound System, Gastroenterology-Urology
510(k) Number K212852
Device Name Areus(TM) Adapt Endoscopic Ultrasound Aspiration Needle, Tridemt(TM) Endoscopic Ultrasound Aspiration Needle
Applicant
Micro-Tech (Nanjing) Co., Ltd.
# 10 Gaoke Third Rd., Nanjing National Hi-Tech,
Industrial Development Zone
Nanjing,  CN 210032
Applicant Contact Cecilia Sun
Correspondent
Micro-Tech (Nanjing) Co., Ltd.
# 10 Gaoke Third Rd., Nanjing National Hi-Tech,
Industrial Development Zone
Nanjing,  CN 210032
Correspondent Contact Cecilia Sun
Regulation Number876.1500
Classification Product Code
ODG  
Subsequent Product Code
FCG  
Date Received09/07/2021
Decision Date 12/06/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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