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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stents, Drains And Dilators For The Biliary Ducts
510(k) Number K253132
Device Name Single use stone retrieval balloons
Applicant
Zhejiang Chuangxiang Medical Technology Co., Ltd.
Rm. 101-1, 201-1, 301, 401, Bldg. 50
#650 Hongfeng Rd., Donghu St., Linping District
Hangzhou,  CN 311100
Applicant Contact Lucius Long
Correspondent
Zhejiang Chuangxiang Medical Technology Co., Ltd.
Rm. 101-1, 201-1, 301, 401, Bldg. 50
#650 Hongfeng Rd., Donghu St., Linping District
Hangzhou,  CN 311100
Correspondent Contact Lucius Long
Regulation Number876.5010
Classification Product Code
FGE  
Date Received09/25/2025
Decision Date 03/06/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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