FDA 510(k)

Luja 弯头

K号: K241210 · 2024-11-21

决定日期2024-11-21

产品代码EZD

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决定实质等同

器械摘要

Luja Coude is the device name listed in this FDA 510(k) record. The listed applicant is Coloplast Corp.. It received FDA 510(k) clearance on 2024-11-21 under 510(k) number K241210. 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 Coude?

Luja Coude is a medical device that received FDA 510(k) clearance on 2024-11-21. The listed applicant is Coloplast Corp.. The 510(k) number is K241210.

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

Luja Coude received FDA 510(k) clearance on 2024-11-21, under 510(k) number K241210.

Who is the listed applicant for Luja Coude?

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 Coude?

The FDA product code for Luja Coude 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。

K252140Heylo™ System K251116Luja 弯头 K250270Luja Set K242049SureCath Set K242173Retrace输尿管通道鞘（ASXL10，ASXL12，ACXL10，ACXL12，AXXL10，AXXL12，ALXL10，ALXL12）K242473Altis单切口悬吊系统（519650）；Aris经闭孔悬吊系统（519551）；Supris经耻骨悬吊系统（519562）

查看所有 25 个设备 →

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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