FDA 510(k)

一次性内镜注射针

K号: K220292 · 2022-08-19

申请人Yangzhou Fartley Medical Instrument Technology Co., Ltd.

决定日期2022-08-19

产品代码FBK

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决定实质等同

器械摘要

Disposable Endoscope Injection Needle is the device name listed in this FDA 510(k) record. The listed applicant is Yangzhou Fartley Medical Instrument Technology Co., Ltd.. It received FDA 510(k) clearance on 2022-08-19 under 510(k) number K220292. The device is classified under product code FBK. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Disposable Endoscope Injection Needle?

Disposable Endoscope Injection Needle is a medical device that received FDA 510(k) clearance on 2022-08-19. The listed applicant is Yangzhou Fartley Medical Instrument Technology Co., Ltd.. The 510(k) number is K220292.

When did Disposable Endoscope Injection Needle receive FDA 510(k) clearance?

Disposable Endoscope Injection Needle received FDA 510(k) clearance on 2022-08-19, under 510(k) number K220292.

Who is the listed applicant for Disposable Endoscope Injection Needle?

FDA 510(k)记录将扬州法尔莱医疗器械科技有限公司列为申请人。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 Disposable Endoscope Injection Needle?

The FDA product code for Disposable Endoscope Injection Needle is FBK.

列明Yangzhou Fartley Medical Instrument Technology Co., Ltd.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。

K260512一次性输尿管通道鞘 K260423一次性内镜远端附件 K250732一次性内窥镜阀门套装 K230004一次性止血夹 K222980Pentax 医疗阀门套装 K220785Clean Connecting Tube

查看所有 9 个设备 →

相关器械（代码：FBK）

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。

官方来源

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