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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 K250128
Device Name Single Use Suction-Evacuation Ureteral Access Sheath
Applicant
Anhui Happiness Workshop Medical Instruments Co., Ltd.
5/F, Bldg. 4,Bengshan Science And Technology Innovation
Park, 1600 Yan’An S. Rd.
Bengbu,  CN 233000
Applicant Contact Shuanghong Wang
Correspondent
Pure Global
111 Town Sq. Pl.
Suite 1203
Jersey City,  NJ  07310
Correspondent Contact Jarvis Wu
Regulation Number876.1500
Classification Product Code
FED  
Date Received01/17/2025
Decision Date 09/19/2025
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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