FDA 510(k)

Cytrans® Elashield

K号: K253317 · 2026-07-06

决定日期2026-07-06

产品代码LYC

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决定实质等同

器械摘要

Cytrans™ Elashield 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 2026-07-06 under 510(k) number K253317. The device is classified under product code LYC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Cytrans™ Elashield?

Cytrans™ Elashield is a medical device that received FDA 510(k) clearance on 2026-07-06. The listed applicant is GC America, Inc.. The 510(k) number is K253317.

When did Cytrans™ Elashield receive FDA 510(k) clearance?

Cytrans™ Elashield received FDA 510(k) clearance on 2026-07-06, under 510(k) number K253317.

Who is the listed applicant for Cytrans™ Elashield?

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 Cytrans™ Elashield?

The FDA product code for Cytrans™ Elashield is LYC.

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 K261246SRGC-06 K254109G-CEM UNIVERSAL K251124G-Bond通用 K250953EQUIA LC ONE K251946G aenial通用注射剂II

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