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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 K231774
Device Name CoralView® Single-use Digital Flexible Ureteroscope (U10); CoralView® Single-use Digital Flexible Ureteroscope (U10-B); CoralView® Single-use Digital Flexible Ureteroscope (U10-BR); CoralView® Single-use Digital Flexible Ureteroscope (U20); CoralView® Single-use Digital Flexible Ureteroscope (U20-B); CoralView® Single-use Digital Flexible Ureteroscope (U20-BR)
Applicant
MacroLux Medical Technology Co., Ltd.
301, Bldg. 3, Namtai Inno Park In Guang Ming Ave.
Guangming
Shenzhen,  CN 518107
Applicant Contact Linbin Ye
Correspondent
MacroLux Medical Technology Co., Ltd.
301, Bldg. 3, Namtai Inno Park In Guang Ming Ave.
Guangming
Shenzhen,  CN 518107
Correspondent Contact Linbin Ye
Regulation Number876.1500
Classification Product Code
FGB  
Date Received06/16/2023
Decision Date 01/11/2024
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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