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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Biopsy
510(k) Number K214063
Device Name Model 121 Biopsy Needle, Model 111 Biopsy Needle, Model 112 Biopsy Needle, and Model 131 Disposable Coaxial Biopsy Needle
Applicant
Guangzhou Shengwei Medical Devices Co., Ltd.
# 126, Guangshao Rd., Aotou Town
Conghua City,  CN 510900
Applicant Contact Xiaojun Cai
Correspondent
Guangzhou Shengwei Medical Devices Co., Ltd.
# 126, Guangshao Rd., Aotou Town
Conghua City,  CN 510900
Correspondent Contact Xiaojun Cai
Regulation Number876.1075
Classification Product Code
KNW  
Subsequent Product Code
FCG  
Date Received12/27/2021
Decision Date 06/03/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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