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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 K251951
Device Name Single-Use Video Flexible Ureterorenoscope (RP-U-C03R9, RP-U-C03R3, RP-U-C03S9, RP-U-C03S3); Endoscopic Video Image Processor (RP-IPD-V2000EF); Endoscopic Video Image Processor (RP-IPD-V1000F)
Applicant
Guangzhou Red Pine Medical Instrument Co., Ltd.
12 F, #87 Luoxuan Ave., Guangzhou International Bioisland, H
Guangzhou,  CN 510000
Applicant Contact Weihua Yang
Correspondent
Guangzhou Red Pine Medical Instrument Co., Ltd.
12 F, #87 Luoxuan Ave., Guangzhou International Bioisland, H
Guangzhou,  CN 510000
Correspondent Contact Ping Yang
Regulation Number876.1500
Classification Product Code
FGB  
Date Received06/25/2025
Decision Date 12/16/2025
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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