FDA 510(k)

离子-C

K号: K251714 · 2026-01-16

决定日期2026-01-16

产品代码MRW

决定实质等同

器械摘要

Ion-C is the device name listed in this FDA 510(k) record. The listed applicant is SurGenTec, LLC. It received FDA 510(k) clearance on 2026-01-16 under 510(k) number K251714. The device is classified under product code MRW. FDA Decision: Substantially Equivalent.

常见问题

What is the Ion-C?

Ion-C is a medical device that received FDA 510(k) clearance on 2026-01-16. The listed applicant is SurGenTec, LLC. The 510(k) number is K251714.

When did Ion-C receive FDA 510(k) clearance?

Ion-C received FDA 510(k) clearance on 2026-01-16, under 510(k) number K251714.

Who is the listed applicant for Ion-C?

FDA 510(k)记录中列出SurGenTec, LLC为申请人。这本身并不能确立该设备的制造商。

What is the FDA product code for Ion-C?

The FDA product code for Ion-C is MRW.

列明SurGenTec, LLC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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