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FDA 510(k)

富士胶片内窥镜型号EC-860P/M; 富士胶片内窥镜型号EC-860P/L; 富士胶片内窥镜型号EC-860S/L

K号: K243261 · 2025-05-23

申请人Fujifilm Corporation
决定日期2025-05-23
产品代码FDF
咨询委员会GU 请注意，由于您只提供了“GU”这个词，我无法提供完整的翻译。如果您能提供完整的句子或段落，我将能够为您提供准确的翻译。
决定实质等同

器械摘要

FUJIFILM Endoscope Model EC-860P/M; FUJIFILM Endoscope Model EC-860P/L; FUJIFILM Endoscope Model EC-860S/L is the device name listed in this FDA 510(k) record. The listed applicant is Fujifilm Corporation. It received FDA 510(k) clearance on 2025-05-23 under 510(k) number K243261. The device is classified under product code FDF. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the FUJIFILM Endoscope Model EC-860P/M; FUJIFILM Endoscope Model EC-860P/L; FUJIFILM Endoscope Model EC-860S/L?

FUJIFILM Endoscope Model EC-860P/M; FUJIFILM Endoscope Model EC-860P/L; FUJIFILM Endoscope Model EC-860S/L is a medical device that received FDA 510(k) clearance on 2025-05-23. The listed applicant is Fujifilm Corporation. The 510(k) number is K243261.

When did FUJIFILM Endoscope Model EC-860P/M; FUJIFILM Endoscope Model EC-860P/L; FUJIFILM Endoscope Model EC-860S/L receive FDA 510(k) clearance?

FUJIFILM Endoscope Model EC-860P/M; FUJIFILM Endoscope Model EC-860P/L; FUJIFILM Endoscope Model EC-860S/L received FDA 510(k) clearance on 2025-05-23, under 510(k) number K243261.

Who is the listed applicant for FUJIFILM Endoscope Model EC-860P/M; FUJIFILM Endoscope Model EC-860P/L; FUJIFILM Endoscope Model EC-860S/L?

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 Endoscope Model EC-860P/M; FUJIFILM Endoscope Model EC-860P/L; FUJIFILM Endoscope Model EC-860S/L?

The FDA product code for FUJIFILM Endoscope Model EC-860P/M; FUJIFILM Endoscope Model EC-860P/L; FUJIFILM Endoscope Model EC-860S/L is FDF.

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

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 6.0K261283APERTO 明亮 MRI 系统K253836FCT iStream 阶段 2K261170BA-004CCK260567EW10-EC02 内窥镜支持程序K261880FUJIFILM 处理器 EP-8000；球囊控制器 PB-30；内窥镜支持程序 EW10-VM01

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相关器械（代码：FDF）

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。

K260503特里顿1系统Neptune Medical, Inc.K261015独立视界结肠镜系统Gi View, Ltd.K261587充气保留装置（IRD）(11173-325-101)BPEndo, LLCK260423一次性内镜远端附件Yangzhou Fartley Medical Instrument Technology Co., Ltd.K252457一次性远端端头胶带罩Shanghai SeeGen Photoelectric Technology Co., Ltd.K244029ROBOPERA（ER-R-002）；ROBOPERA（ER-R-003）Endorobotics Co., Ltd.

官方来源

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