FDA 510(k)

一次性内镜套管

K号: K180208 · 2018-04-09

决定日期2018-04-09

产品代码GCJ

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决定实质等同

器械摘要

Disposable Endoscopic Trocar is the device name listed in this FDA 510(k) record. The listed applicant is Fengh Medical Co., Ltd.. It received FDA 510(k) clearance on 2018-04-09 under 510(k) number K180208. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Disposable Endoscopic Trocar?

Disposable Endoscopic Trocar is a medical device that received FDA 510(k) clearance on 2018-04-09. The listed applicant is Fengh Medical Co., Ltd.. The 510(k) number is K180208.

When did Disposable Endoscopic Trocar receive FDA 510(k) clearance?

Disposable Endoscopic Trocar received FDA 510(k) clearance on 2018-04-09, under 510(k) number K180208.

Who is the listed applicant for Disposable Endoscopic Trocar?

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

What is the FDA product code for Disposable Endoscopic Trocar?

The FDA product code for Disposable Endoscopic Trocar is GCJ.

列明Fengh Medical 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。

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相关器械（代码：GCJ）

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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