FDA 510(k)

Guardenia（GAR-1）

K号: K232701 · 2023-09-29

决定日期2023-09-29

产品代码GCJ

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决定实质等同

器械摘要

Guardenia (GAR-1) is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Surgical Concepts. It received FDA 510(k) clearance on 2023-09-29 under 510(k) number K232701. 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 Guardenia (GAR-1)?

Guardenia (GAR-1) is a medical device that received FDA 510(k) clearance on 2023-09-29. The listed applicant is Advanced Surgical Concepts. The 510(k) number is K232701.

When did Guardenia (GAR-1) receive FDA 510(k) clearance?

Guardenia (GAR-1) received FDA 510(k) clearance on 2023-09-29, under 510(k) number K232701.

Who is the listed applicant for Guardenia (GAR-1)?

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

What is the FDA product code for Guardenia (GAR-1)?

The FDA product code for Guardenia (GAR-1) is GCJ.

列明Advanced Surgical Concepts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。

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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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