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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Biopsy Needle
510(k) Number K191472
Device Name Biopsy Needle
Applicant
Ushare Medical, Inc.
445 An Ji Zhong Rd., San Zao Town
Zhuhai,  CN 519090
Applicant Contact Yan Wang
Correspondent
Shanghai SUNGO Management Consulting Co., Ltd.
13th F, 1500# Century Ave.
Shanghai,  CN 200122
Correspondent Contact Raymond Luo
Regulation Number876.1075
Classification Product Code
FCG  
Subsequent Product Code
KNW  
Date Received06/03/2019
Decision Date 01/29/2020
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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