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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 K260512
Device Name Disposable Ureteral Access Sheath
Applicant
Yangzhou Fartley Medical Instrument Technology Co., Ltd.
# 7 Youkang Rd., Touqiao Town, Guangling District, Yangzhou,
Yangzhou,  CN 225000
Applicant Contact Xi Han
Correspondent
Yangzhou Fartley Medical Instrument Technology Co., Ltd.
# 7 Youkang Rd., Touqiao Town, Guangling District, Yangzhou,
Yangzhou,  CN 225000
Correspondent Contact Xi Han
Regulation Number876.1500
Classification Product Code
FED  
Date Received02/17/2026
Decision Date 09/21/2026
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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