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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cystoscope And Accessories, Flexible/Rigid
510(k) Number K252598
Device Name Flexible Cystoscope (CY50H-20EU, CY50H-20US, CY55H-24EU, CY55H-24US)
Applicant
Shanghai AnQing Medical Instrument Co., Ltd.
3 & 4 Floor, #2 Bldg., 366 Huiqing Rd.
East Zhangjiang High-Tech Park
Shanghai,  CN 201201
Applicant Contact Shuwen Fan
Correspondent
Shanghai AnQing Medical Instrument Co., Ltd.
3 & 4 Floor, #2 Bldg., 366 Huiqing Rd.
East Zhangjiang High-Tech Park
Shanghai,  CN 201201
Correspondent Contact Shuwen Fan
Regulation Number876.1500
Classification Product Code
FAJ  
Date Received08/18/2025
Decision Date 09/15/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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