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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ureteroscope And Accessories, Flexible/Rigid
510(k) Number K240374
Device Name Ureterorenoscope System
Applicant
Shenzhen HugeMed Medical Technical Development Co., Ltd.
401, 501, Bldg. 4, Haizhi Technology Park, Fortis, #17
Bulan Rd.,Xialilang Community, Nanwan St., Longgang District
Shenzhen,  CN 518115
Applicant Contact Cathy Shi
Correspondent
Shenzhen Chonconn Medical Device Consulting Co., Ltd.
Rm. 504, Block C, # 1029 Nanhai Ave.
Nanshan District
Shenzhen,  CN
Correspondent Contact Jie Yang
Regulation Number876.1500
Classification Product Code
FGB  
Date Received02/07/2024
Decision Date 05/10/2024
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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