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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 K252468
Device Name Single-use Digital Flexible Ureteroscope (GY-UR9.3); Single-use Digital Flexible Ureteroscope (GY-UR8.4); Single-use Digital Flexible Ureteroscope (GY-UR7.5); Endoscope camera system (GY-AIO-121)
Applicant
Zhejiang Geyi Medical Instrument Co., Ltd.
# 1, 2 Factory, # 5, Hutang Rd. Xiaya Town
Jiande City,  CN 311606
Applicant Contact Cathy Tan
Correspondent
Zhejiang Geyi Medical Instrument Co., Ltd.
# 1, 2 Factory, # 5, Hutang Rd. Xiaya Town
Jiande City,  CN 311606
Correspondent Contact Cathy Tan
Regulation Number876.1500
Classification Product Code
FGB  
Date Received08/06/2025
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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