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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 K251823
Device Name UE BRONCHO Single-Use Bronchoscopes (EBS-380C); UE BRONCHO Single-Use Bronchoscopes (EBS-500C); UE BRONCHO Single-Use Bronchoscopes (EBS-600C); UE Display (UE-M10S)
Applicant
Zhejiang UE Medical Corp.
#8, Youyi Rd.
Baita Economic Development Zone, Xianju
Taizhou,  CN 317300
Applicant Contact Carol He
Correspondent
Chonconn Consulting Co., Ltd.
Rm. 504, Block C, # 1029 Nanhai Ave.
Nanshan District
Shenzhen,  CN
Correspondent Contact Jie Yang
Regulation Number874.4680
Classification Product Code
EOQ  
Date Received06/13/2025
Decision Date 08/11/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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