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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 K240283
Device Name BubbleView™ Single-Use Digital Flexible Cystoscope (C50-C, C50-CR, C50-CB, C50-CBR); ViewHub® Video Processor (S13, S13-T, S13-N, S13-S)
Applicant
MacroLux Medical Technology Co., Ltd.
301, Building 3, NamTai Inno Park In Guang Ming Avenue
Guangming
Shenzhen,  CN
Applicant Contact Linbin Ye
Correspondent
MacroLux Medical Technology Co., Ltd.
301, Building 3, NamTai Inno Park In Guang Ming Avenue
Guangming
Shenzhen,  CN
Correspondent Contact Linbin Ye
Regulation Number876.1500
Classification Product Code
FAJ  
Date Received02/01/2024
Decision Date 06/10/2024
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
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