FDA 510(k)

间歇性nelaton导尿管（一次性使用）

K号: K222677 · 2023-04-05

决定日期2023-04-05

产品代码EZD

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决定实质等同

器械摘要

Intermittent nelaton catheter for single use is the device name listed in this FDA 510(k) record. The listed applicant is Hangzhou Jimushi Meditech Co., Ltd.. It received FDA 510(k) clearance on 2023-04-05 under 510(k) number K222677. 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 Intermittent nelaton catheter for single use?

Intermittent nelaton catheter for single use is a medical device that received FDA 510(k) clearance on 2023-04-05. The listed applicant is Hangzhou Jimushi Meditech Co., Ltd.. The 510(k) number is K222677.

When did Intermittent nelaton catheter for single use receive FDA 510(k) clearance?

Intermittent nelaton catheter for single use received FDA 510(k) clearance on 2023-04-05, under 510(k) number K222677.

Who is the listed applicant for Intermittent nelaton catheter for single use?

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

What is the FDA product code for Intermittent nelaton catheter for single use?

The FDA product code for Intermittent nelaton catheter for single use is EZD.

列明Hangzhou Jimushi Meditech 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。

K260394一次性使用亲水性涂层间歇性纳拉通导尿管（NCR）K200134吉姆氏一次性无菌尿道导管

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

官方来源

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