FDA 510(k)

无刀Trocar；有刀Trocar；Hasson Trocar

K号: K241052 · 2024-10-04

决定日期2024-10-04

产品代码GCJ

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

Bladeless Trocar; Bladed Trocar; Hasson Trocar is the device name listed in this FDA 510(k) record. The listed applicant is Advamedix, GmbH. It received FDA 510(k) clearance on 2024-10-04 under 510(k) number K241052. 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 Bladeless Trocar; Bladed Trocar; Hasson Trocar?

Bladeless Trocar; Bladed Trocar; Hasson Trocar is a medical device that received FDA 510(k) clearance on 2024-10-04. The listed applicant is Advamedix, GmbH. The 510(k) number is K241052.

When did Bladeless Trocar; Bladed Trocar; Hasson Trocar receive FDA 510(k) clearance?

Bladeless Trocar; Bladed Trocar; Hasson Trocar received FDA 510(k) clearance on 2024-10-04, under 510(k) number K241052.

Who is the listed applicant for Bladeless Trocar; Bladed Trocar; Hasson Trocar?

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 Bladeless Trocar; Bladed Trocar; Hasson Trocar?

The FDA product code for Bladeless Trocar; Bladed Trocar; Hasson Trocar 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。

K242927吸水冲洗管套装

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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官方来源

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