FDA 510(k)

一次性使用亲水性涂层间歇性纳拉通导尿管（NCR）

K号: K260394 · 2026-06-24

决定日期2026-06-24

产品代码EZD

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决定实质等同

器械摘要

Hydrophilic coated intermittent nalaton catheter for single use-ready to use (NCR) 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 2026-06-24 under 510(k) number K260394. 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 Hydrophilic coated intermittent nalaton catheter for single use-ready to use (NCR)?

Hydrophilic coated intermittent nalaton catheter for single use-ready to use (NCR) is a medical device that received FDA 510(k) clearance on 2026-06-24. The listed applicant is Hangzhou Jimushi Meditech Co., Ltd.. The 510(k) number is K260394.

When did Hydrophilic coated intermittent nalaton catheter for single use-ready to use (NCR) receive FDA 510(k) clearance?

Hydrophilic coated intermittent nalaton catheter for single use-ready to use (NCR) received FDA 510(k) clearance on 2026-06-24, under 510(k) number K260394.

Who is the listed applicant for Hydrophilic coated intermittent nalaton catheter for single use-ready to use (NCR)?

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 Hydrophilic coated intermittent nalaton catheter for single use-ready to use (NCR)?

The FDA product code for Hydrophilic coated intermittent nalaton catheter for single use-ready to use (NCR) 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。

K222677间歇性nelaton导尿管（一次性使用）K200134吉姆氏一次性无菌尿道导管

官方来源

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