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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscopic Access Overtube, Gastroenterology-Urology
510(k) Number K230748
Device Name Disposable Ureteral Access Sheath
Applicant
Youcare Technology Co.,Ltd. (Wuhan)
Tangxunhu N. St.
Wuhan,  CN 430000
Applicant Contact Bing Hu
Correspondent
Youcare Technology Co.,Ltd. (Wuhan)
Tangxunhu N. St.
Wuhan,  CN 430000
Correspondent Contact Bing Hu
Regulation Number876.1500
Classification Product Code
FED  
Date Received03/17/2023
Decision Date 08/02/2023
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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