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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
510(k) Number K212999
Device Name Multi-Functional Electrosurgical Knife
Applicant
Anrei Medical (Hangzhou) Co., Ltd.
#3 Ave.8, Heda
Hangzhou,  CN 310018
Applicant Contact Huibing Yang
Correspondent
Anrei Medical (Hangzhou) Co., Ltd.
#3 Ave.8, Heda
Hangzhou,  CN 310018
Correspondent Contact Huibing Yang
Regulation Number876.4300
Classification Product Code
KNS  
Date Received09/20/2021
Decision Date 03/21/2022
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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