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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 K250049
Device Name Medical Video Endoscope [Standard Deflection] (URS3005); Medical Video Endoscope [Reverse Deflection] (URS3005E); Medical Video Endoscope [Standard Deflection] (URS3006); Medical Video Endoscope [Reverse Deflection] (URS3006E); Medical Video Endoscope [Standard Deflection] (URS3016); Medical Video Endoscope [Reverse Deflection] (URS3016E); Image processor (DIS8000)
Applicant
Seplou (Zhuhai) Co., Ltd.
5th Floor, Bldg. 1, # 8, Keji 10th Rd.,
Tangjiawan Town, High-Tech Zone
Zhuhai,  CN 519085
Applicant Contact QingFu Zeng
Correspondent
Chonconn 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 Received01/10/2025
Decision Date 08/26/2025
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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