FDA 510(k)

吸水冲洗管套装

K号: K242927 · 2024-11-22

决定日期2024-11-22

产品代码GCJ

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决定实质等同

器械摘要

Suction Irrigation Tubing Set is the device name listed in this FDA 510(k) record. The listed applicant is Advamedix, GmbH. It received FDA 510(k) clearance on 2024-11-22 under 510(k) number K242927. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Suction Irrigation Tubing Set?

Suction Irrigation Tubing Set is a medical device that received FDA 510(k) clearance on 2024-11-22. The listed applicant is Advamedix, GmbH. The 510(k) number is K242927.

When did Suction Irrigation Tubing Set receive FDA 510(k) clearance?

Suction Irrigation Tubing Set received FDA 510(k) clearance on 2024-11-22, under 510(k) number K242927.

Who is the listed applicant for Suction Irrigation Tubing Set?

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

What is the FDA product code for Suction Irrigation Tubing Set?

The FDA product code for Suction Irrigation Tubing Set is GCJ.

列明Advamedix, GmbH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。

K241052无刀Trocar；有刀Trocar；Hasson Trocar

相关器械（代码：GCJ）

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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