FDA 510(k)

Endura®输尿管支架和支架套装

K号: K251469 · 2025-12-19

决定日期2025-12-19

产品代码FAD

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Unknown

器械摘要

Endura™ Ureteral Stent and Stent Set is the device name listed in this FDA 510(k) record. The listed applicant is Cathegenix (Xiamen) Co., Ltd.. It received FDA 510(k) clearance on 2025-12-19 under 510(k) number K251469. The device is classified under product code FAD. It was reviewed by the GU advisory panel. FDA Decision: Unknown.

常见问题

What is the Endura™ Ureteral Stent and Stent Set?

Endura™ Ureteral Stent and Stent Set is a medical device that received FDA 510(k) clearance on 2025-12-19. The listed applicant is Cathegenix (Xiamen) Co., Ltd.. The 510(k) number is K251469.

When did Endura™ Ureteral Stent and Stent Set receive FDA 510(k) clearance?

Endura™ Ureteral Stent and Stent Set received FDA 510(k) clearance on 2025-12-19, under 510(k) number K251469.

Who is the listed applicant for Endura™ Ureteral Stent and Stent Set?

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

What is the FDA product code for Endura™ Ureteral Stent and Stent Set?

The FDA product code for Endura™ Ureteral Stent and Stent Set is FAD.

列明Cathegenix (Xiamen) 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。

K250585LumenaTM输尿管通道鞘

相关器械（代码：FAD）

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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