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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 K180367
Device Name Ureterorenoscope System
Applicant
Shanghai AnQing Medical Instrument Co., Ltd.
150 Cailun Rd., Zhangjiang High-Tech Park
Shanghai,  CN 201210
Applicant Contact Lina FEI
Correspondent
Shanghai AnQing Medical Instrument Co., Ltd.
150 Cailun Rd., Zhangjiang High-Tech Park
Shanghai,  CN 201210
Correspondent Contact Lina FEI
Regulation Number876.1500
Classification Product Code
FGB  
Date Received02/12/2018
Decision Date 07/03/2018
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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