自用闭式导尿系统及自用闭式导尿系统+
K号: K221401 · 2022-12-02
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申请人Coloplast
决定日期2022-12-02
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
Self-Cath and Self-Cath Plus is the device name listed in this FDA 510(k) record. The listed applicant is Coloplast. It received FDA 510(k) clearance on 2022-12-02 under 510(k) number K221401. 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 Self-Cath and Self-Cath Plus?
Self-Cath and Self-Cath Plus is a medical device that received FDA 510(k) clearance on 2022-12-02. The listed applicant is Coloplast. The 510(k) number is K221401.
When did Self-Cath and Self-Cath Plus receive FDA 510(k) clearance?
Self-Cath and Self-Cath Plus received FDA 510(k) clearance on 2022-12-02, under 510(k) number K221401.
Who is the listed applicant for Self-Cath and Self-Cath Plus?
The FDA 510(k) record lists Coloplast as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Self-Cath and Self-Cath Plus?
The FDA product code for Self-Cath and Self-Cath Plus is EZD.
列明Coloplast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。
K241028Luja女性（20051）；Luja女性（20052）；Luja女性（20054）；Luja女性（20056）K231891美德男性吊带系统及艾利克斯伤口拉钩便捷套装K230165Luja 弯头（20118 男 CH8 - 小包装（口袋大小）），Luja 弯头（20111 男 CH10 - 小包装（口袋大小）），Luja 弯头（20112 男 CH12 - 小包装（口袋大小）），Luja 弯头（20114 男 CH14 - 小包装（口袋大小）），Luja 弯头 (20101 男 CH10 - 大包装)，Luja 弯头 (20102 男 CH12 - 大包装)，Luja 弯头 (20104 男 CH14 - 大包装)，Luja 弯头 (20106 男 CH16 - 大包装)K223821自用闭式导尿系统K222059SpeediCath Flex 套件K210250SpeedCath 紧凑型男性
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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