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FDA 510(k)

UE BRONCHO 单次使用支气管镜（EBS-380C）；UE BRONCHO 单次使用支气管镜（EBS-500C）；UE BRONCHO 单次使用支气管镜（EBS-600C）；UE 显示器（UE-M10S）

K号: K251823 · 2025-08-11

申请人Zhejiang UE Medical Corp.
决定日期2025-08-11
产品代码EOQ
咨询委员会医疗设备监管文本描述翻译如下： 关于[公司/产品名称]的监管信息： - 美国食品药品监督管理局（FDA）批准号：[510(k)编号] - 预市场批准（PMA）申请号：[PMA编号] - 临床试验注册号（NCT）：[NCT编号] - 医学文献标识符（PMID）：[PMID编号] - 产品标识符：[标识符] - 相关政策：医疗监管政策v1 - 更多信息请访问：[URL] 请注意，以上翻译保留了公司/产品名称、FDA、510(k)、PMA、NCT、PMID、标识符和URL。
决定实质等同

器械摘要

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) is the device name listed in this FDA 510(k) record. The listed applicant is Zhejiang UE Medical Corp.. It received FDA 510(k) clearance on 2025-08-11 under 510(k) number K251823. The device is classified under product code EOQ. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the 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)?

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) is a medical device that received FDA 510(k) clearance on 2025-08-11. The listed applicant is Zhejiang UE Medical Corp.. The 510(k) number is K251823.

When did 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) receive FDA 510(k) clearance?

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) received FDA 510(k) clearance on 2025-08-11, under 510(k) number K251823.

Who is the listed applicant for 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)?

The FDA 510(k) record lists Zhejiang UE Medical Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 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)?

The FDA product code for 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) is EOQ.

相关临床试验

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

NCT07608549FLASHPilot 1期安全性研究NOT_YET_RECRUITINGNCT06562205PAP系统外部临床研究（ECS）NOT_YET_RECRUITINGNCT06443177交感神经调节对动脉瘤性蛛网膜下腔出血继发脑动脉痉挛的影响SUSPENDEDNCT07095751人工智能辅助尿路摄像头评估系统，用于诊断膀胱癌NOT_YET_RECRUITING

相关器械（代码：EOQ）

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K261637一次性使用柔性支气管镜Hunan Vathin Medical Instrument Co., Ltd.K260309Ambu® aScope™ 5 Broncho 2.7/1.2；Ambu® aScope™ 5 Broncho 4.2/2.2；Ambu® aScope™ 5 Broncho 4.2/2.2 样本套装Ambu A/SK2540263.8mm 精薄型 ProVu 视频支气管镜（090-02-0038U）；5.0mm 标准型 ProVu 视频支气管镜（090-02-0050U）；6.0mm 大型 ProVu 视频支气管镜（090-02-0060U）；ProVu 视频支气管镜 8 显示器（040-07-0082U）Flexicare Medical Limited.K260382MONARCH™ 平台（MON-000008）Auris Health, Inc.K254037LungFlow气道导管Free Flow Medical, Inc.K253137富士胶片内窥镜型号EB-840S; 富士胶片内窥镜型号EB-840TFujifilm Corporation

官方来源

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数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。

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