Luja 弯头（20108 男 CH18 - 大包装）
K号: K233101 · 2023-10-26
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决定日期2023-10-26
产品代码EZD
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。
决定实质等同
器械摘要
Luja Coude (20108 Male CH18 - large packaging) is the device name listed in this FDA 510(k) record. The listed applicant is Coloplast Corp.. It received FDA 510(k) clearance on 2023-10-26 under 510(k) number K233101. 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 (20108 Male CH18 - large packaging)?
Luja Coude (20108 Male CH18 - large packaging) is a medical device that received FDA 510(k) clearance on 2023-10-26. The listed applicant is Coloplast Corp.. The 510(k) number is K233101.
When did Luja Coude (20108 Male CH18 - large packaging) receive FDA 510(k) clearance?
Luja Coude (20108 Male CH18 - large packaging) received FDA 510(k) clearance on 2023-10-26, under 510(k) number K233101.
Who is the listed applicant for Luja Coude (20108 Male CH18 - large packaging)?
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 (20108 Male CH18 - large packaging)?
The FDA product code for Luja Coude (20108 Male CH18 - large packaging) is EZD.
相关临床试验
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。
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。
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 MedicalK260737Cure 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）。ConvatecK261658LoFric Origo Pro CoudéWellspect ABK262045Luja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
官方来源
在 FDA 数据库中查看 →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。
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