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FDA 510(k)

LEONI 激光光纤：一次性BareFiber，可重复使用BareFiber和一次性内窥镜

K号: K201171 · 2021-04-02

申请人Leoni Fiber Optics, Inc.
决定日期2021-04-02
产品代码GEX
咨询委员会SU 请注意，您提供的文本“SU”不足以进行翻译。请提供完整的描述性文本以便进行翻译。
决定实质等同

器械摘要

LEONI Laser Fibers: BareFiber Disposable, BareFiber Reusable and Endoprobe Disposable is the device name listed in this FDA 510(k) record. The listed applicant is Leoni Fiber Optics, Inc.. It received FDA 510(k) clearance on 2021-04-02 under 510(k) number K201171. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

常见问题

What is the LEONI Laser Fibers: BareFiber Disposable, BareFiber Reusable and Endoprobe Disposable?

LEONI Laser Fibers: BareFiber Disposable, BareFiber Reusable and Endoprobe Disposable is a medical device that received FDA 510(k) clearance on 2021-04-02. The listed applicant is Leoni Fiber Optics, Inc.. The 510(k) number is K201171.

When did LEONI Laser Fibers: BareFiber Disposable, BareFiber Reusable and Endoprobe Disposable receive FDA 510(k) clearance?

LEONI Laser Fibers: BareFiber Disposable, BareFiber Reusable and Endoprobe Disposable received FDA 510(k) clearance on 2021-04-02, under 510(k) number K201171.

Who is the listed applicant for LEONI Laser Fibers: BareFiber Disposable, BareFiber Reusable and Endoprobe Disposable?

The FDA 510(k) record lists Leoni Fiber Optics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LEONI Laser Fibers: BareFiber Disposable, BareFiber Reusable and Endoprobe Disposable?

The FDA product code for LEONI Laser Fibers: BareFiber Disposable, BareFiber Reusable and Endoprobe Disposable is GEX. This falls under the Gastroenterology category.

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：GEX）

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。

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