FDA 510(k)

G aenial通用注射剂II

K号: K251946 · 2025-08-29

决定日期2025-08-29

产品代码EBF

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决定实质等同

器械摘要

G aenial Universal Injectable II is the device name listed in this FDA 510(k) record. The listed applicant is GC America, Inc.. It received FDA 510(k) clearance on 2025-08-29 under 510(k) number K251946. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the G aenial Universal Injectable II?

G aenial Universal Injectable II is a medical device that received FDA 510(k) clearance on 2025-08-29. The listed applicant is GC America, Inc.. The 510(k) number is K251946.

When did G aenial Universal Injectable II receive FDA 510(k) clearance?

G aenial Universal Injectable II received FDA 510(k) clearance on 2025-08-29, under 510(k) number K251946.

Who is the listed applicant for G aenial Universal Injectable II?

FDA 510(k)记录中列出GC America, Inc.为申请人。这本身并不足以确立该设备的制造商。

What is the FDA product code for G aenial Universal Injectable II?

The FDA product code for G aenial Universal Injectable II is EBF.

列明GC America, Inc.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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