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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stent, Ureteral
510(k) Number K243830
Device Name Disposable ureteral stent
Applicant
Shenzhen Trious Medical Technology Co., Ltd.
Rm.102-2, Longtian Tongfuyu Ind Estate #11-3, And Rm.401 &
402, Bldg. D3, Yingzhan S&T Estate, Longtian Tongfuyu Rd. #8
Shenzhen,  CN
Applicant Contact Yingfang Yi
Correspondent
Landlink Healthcare Technology (Shanghai) Co., Ltd.
Rm. 1308, Baohua International Plz.
West Guangzhong Rd. 555, Jingan District
Shanghai,  CN
Correspondent Contact Kyra Kang
Regulation Number876.4620
Classification Product Code
FAD  
Date Received12/13/2024
Decision Date 05/14/2025
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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