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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscopic Injection Needle, Gastroenterology-Urology
510(k) Number K210917
Device Name Single Use Injection Needle
Applicant
Anrei Medical (Hangzhou) Co., Ltd.
No.3 Ave.8, HEDA
Hangzhou,  CN 310018
Applicant Contact Huibing Yang
Correspondent
Anrei Medical (Hangzhou) Co., Ltd.
No.3 Ave.8, HEDA
Hangzhou,  CN 310018
Correspondent Contact Huibing Yang
Regulation Number876.1500
Classification Product Code
FBK  
Date Received03/29/2021
Decision Date 05/28/2021
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
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