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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 K260410
Device Name Single Use Ureteral Access Sheath
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 Haishao Wei
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 Haishao Wei
Regulation Number876.1500
Classification Product Code
FED  
Date Received02/09/2026
Decision Date 09/11/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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