FDA 510(k)

FUJIFILM 处理器 EP-8000；球囊控制器 PB-30；内窥镜支持程序 EW10-VM01

K号: K261880 · 2026-07-02

决定日期2026-07-02

产品代码FET

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决定实质等同

器械摘要

FUJIFILM Processor EP-8000;Balloon Controller PB-30;Endoscopy Support Program EW10-VM01 is the device name listed in this FDA 510(k) record. The listed applicant is Fujifilm Corporation. It received FDA 510(k) clearance on 2026-07-02 under 510(k) number K261880. The device is classified under product code FET. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the FUJIFILM Processor EP-8000;Balloon Controller PB-30;Endoscopy Support Program EW10-VM01?

FUJIFILM Processor EP-8000;Balloon Controller PB-30;Endoscopy Support Program EW10-VM01 is a medical device that received FDA 510(k) clearance on 2026-07-02. The listed applicant is Fujifilm Corporation. The 510(k) number is K261880.

When did FUJIFILM Processor EP-8000;Balloon Controller PB-30;Endoscopy Support Program EW10-VM01 receive FDA 510(k) clearance?

FUJIFILM Processor EP-8000;Balloon Controller PB-30;Endoscopy Support Program EW10-VM01 received FDA 510(k) clearance on 2026-07-02, under 510(k) number K261880.

Who is the listed applicant for FUJIFILM Processor EP-8000;Balloon Controller PB-30;Endoscopy Support Program EW10-VM01?

FDA 510(k)记录中列出富士胶片公司为申请人。这本身并不足以确立该设备制造商的身份。

What is the FDA product code for FUJIFILM Processor EP-8000;Balloon Controller PB-30;Endoscopy Support Program EW10-VM01?

The FDA product code for FUJIFILM Processor EP-8000;Balloon Controller PB-30;Endoscopy Support Program EW10-VM01 is FET.

列明Fujifilm Corporation为申报人的其他记录

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。

K261229SCENARIA 视觉阶段 6.0 K261283APERTO 明亮 MRI 系统 K253836FCT iStream 阶段 2 K261170BA-004CC K260567EW10-EC02 内窥镜支持程序 K253137富士胶片内窥镜型号EB-840S; 富士胶片内窥镜型号EB-840T

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官方来源

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