FDA 510(k)

Clear-Tip EUS-FNA

K号: K180363 · 2018-11-01

决定日期2018-11-01

产品代码FCG

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决定实质等同

器械摘要

Clear-Tip EUS-FNA is the device name listed in this FDA 510(k) record. The listed applicant is Finemedix Co., Ltd.. It received FDA 510(k) clearance on 2018-11-01 under 510(k) number K180363. The device is classified under product code FCG. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Clear-Tip EUS-FNA?

Clear-Tip EUS-FNA is a medical device that received FDA 510(k) clearance on 2018-11-01. The listed applicant is Finemedix Co., Ltd.. The 510(k) number is K180363.

When did Clear-Tip EUS-FNA receive FDA 510(k) clearance?

Clear-Tip EUS-FNA received FDA 510(k) clearance on 2018-11-01, under 510(k) number K180363.

Who is the listed applicant for Clear-Tip EUS-FNA?

The FDA 510(k) record lists Finemedix Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Clear-Tip EUS-FNA?

The FDA product code for Clear-Tip EUS-FNA is FCG.

列明Finemedix 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。

K251478ClearTip TBNA 类型 K250994ClearTip FNA 和 FNB 类型 K242857ClearHemograsper K242134ClearCap远端附件 K231267ClearTip K202616ClearCap远端附件

查看所有 11 个设备 →

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。