FDA 510(k)

G-Bond通用

K号: K251124 · 2025-10-02

决定日期2025-10-02

产品代码KLE

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决定实质等同

器械摘要

G-Bond Universal 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 2025-10-02 under 510(k) number K251124. The device is classified under product code KLE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the G-Bond Universal?

G-Bond Universal is a medical device that received FDA 510(k) clearance on 2025-10-02. The listed applicant is GC America, Inc.. The 510(k) number is K251124.

When did G-Bond Universal receive FDA 510(k) clearance?

G-Bond Universal received FDA 510(k) clearance on 2025-10-02, under 510(k) number K251124.

Who is the listed applicant for G-Bond Universal?

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-Bond Universal?

The FDA product code for G-Bond Universal is KLE.

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。

K262202Cerasmart Forte K253317Cytrans® Elashield K261246SRGC-06 K254109G-CEM UNIVERSAL K250953EQUIA LC ONE K251946G aenial通用注射剂II

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官方来源

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数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。