FDA 510(k)

Coude袖套IC；Coude Plus袖套IC

K号: K253295 · 2026-05-18

决定日期2026-05-18

产品代码EZD

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决定实质等同

器械摘要

Coude Sleeved IC; Coude Plus Sleeved IC is the device name listed in this FDA 510(k) record. The listed applicant is Hollister Incorporated. It received FDA 510(k) clearance on 2026-05-18 under 510(k) number K253295. 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 Coude Sleeved IC; Coude Plus Sleeved IC?

Coude Sleeved IC; Coude Plus Sleeved IC is a medical device that received FDA 510(k) clearance on 2026-05-18. The listed applicant is Hollister Incorporated. The 510(k) number is K253295.

When did Coude Sleeved IC; Coude Plus Sleeved IC receive FDA 510(k) clearance?

Coude Sleeved IC; Coude Plus Sleeved IC received FDA 510(k) clearance on 2026-05-18, under 510(k) number K253295.

Who is the listed applicant for Coude Sleeved IC; Coude Plus Sleeved IC?

The FDA 510(k) record lists Hollister Incorporated as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Coude Sleeved IC; Coude Plus Sleeved IC?

The FDA product code for Coude Sleeved IC; Coude Plus Sleeved IC is EZD.

列明Hollister Incorporated为申报人的其他记录

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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。

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