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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bronchoscope (Flexible Or Rigid)
510(k) Number K260420
Device Name LoopView® Single-Use Digital Flexible Bronchoscope (B27-C, B27-CG)
Applicant
MacroLux Medical Technology Co., Ltd.
301, Bldg. 3, Namtai Inno Park In Guang Ming Ave.
Shenzhen,  CN 518107
Applicant Contact Ye Linbin
Correspondent
MacroLux Medical Technology Co., Ltd.
301, Bldg. 3, Namtai Inno Park In Guang Ming Ave.
Shenzhen,  CN 518107
Correspondent Contact Ye Linbin
Regulation Number874.4680
Classification Product Code
EOQ  
Date Received02/09/2026
Decision Date 04/08/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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