FDA 510(k)

Luja 弯头

K号: K251116 · 2025-06-27

决定日期2025-06-27

产品代码EZD

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决定实质等同

器械摘要

Luja Coudé is the device name listed in this FDA 510(k) record. The listed applicant is Coloplast Corp.. It received FDA 510(k) clearance on 2025-06-27 under 510(k) number K251116. The device is classified under product code EZD. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Luja Coudé?

Luja Coudé is a medical device that received FDA 510(k) clearance on 2025-06-27. The listed applicant is Coloplast Corp.. The 510(k) number is K251116.

When did Luja Coudé receive FDA 510(k) clearance?

Luja Coudé received FDA 510(k) clearance on 2025-06-27, under 510(k) number K251116.

Who is the listed applicant for Luja Coudé?

The FDA 510(k) record lists Coloplast Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Luja Coudé?

The FDA product code for Luja Coudé is EZD.

列明Coloplast Corp.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：EZD）

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。

K261418Liquick X-treme，Liquick X-treme PlusTeleflex Medical K260737Cure Aqua™ 即用型亲水性间歇导尿管女性用（CH06 - CH16）；Cure Aqua™ 即用型亲水性间歇导尿管男性直型（CH06 - CH18）；Cure Aqua™ 即用型亲水性间歇导尿管男性弯型（CH10 - CH18）。Convatec K261658LoFric Origo Pro CoudéWellspect AB K262045Luja软性产品Coloplast A.S.K260394一次性使用亲水性涂层间歇性纳拉通导尿管（NCR）Hangzhou Jimushi Meditech Co., Ltd.K253295Coude袖套IC；Coude Plus袖套ICHollister Incorporated

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