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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Forceps, Biopsy, Electric
510(k) Number K202438
Device Name Ensure Single-Use Coagulation Forceps
Applicant
Micro-Tech (Nanjing) Co., Ltd.
# 10 Gaoke Thrid Rd.
Nanjing,  CN 210032
Applicant Contact Cecilia Sun
Correspondent
Micro-Tech (Nanjing) Co., Ltd.
# 10 Gaoke Third Rd.
Nanjing,  CN 210032
Correspondent Contact Cecilia Sun
Regulation Number876.4300
Classification Product Code
KGE  
Date Received08/25/2020
Decision Date 03/15/2021
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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