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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Snare, Flexible
510(k) Number K220089
Device Name Disposable Polyp Snare
Applicant
Jiangsu Vedkang Medical Science and Technology Co., Ltd.
#52, Guoxiang Rd., Wujin Economic
Development Zone
Changzhou,  CN 213149
Applicant Contact Tang Ting
Correspondent
Shenzhen Joyantech Consulting Co., Ltd.
1713a, 17th Floor, Block A, Zhongguan Times Sq.
Nanshan District
Shenzhen,  CN 518000
Correspondent Contact Joyce Yang
Regulation Number876.4300
Classification Product Code
FDI  
Subsequent Product Code
FGX  
Date Received01/11/2022
Decision Date 09/22/2022
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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