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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Colonoscope And Accessories, Flexible/Rigid
510(k) Number K260423
Device Name Disposable Endoscopic Distal Attachments
Applicant
Yangzhou Fartley Medical Instrument Technology Co., Ltd.
Beizhou Rd. Lidian Town Guangling District Yangzhou Jiangsu
225106, China
Yangzhou,  CN 225106
Applicant Contact Xi Han
Correspondent
Yangzhou Fartley Medical Instrument Technology Co., Ltd.
Beizhou Rd. Lidian Town Guangling District Yangzhou Jiangsu
225106, China
Yangzhou,  CN 225106
Correspondent Contact Xi Han
Regulation Number876.1500
Classification Product Code
FDF  
Subsequent Product Code
FDS  
Date Received02/09/2026
Decision Date 05/28/2026
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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