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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 K243857
Device Name Flexible Ureterorenoscope (US27F-12-EU; US27F-12-US)
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
FGB  
Date Received12/16/2024
Decision Date 04/11/2025
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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