FDA 510(k)

Hugo® RAS 系统

K号: K250725 · 2025-12-03

决定日期2025-12-03

产品代码SCV

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决定实质等同

器械摘要

Hugo™ RAS System is the device name listed in this FDA 510(k) record. The listed applicant is Covidien, LLC. It received FDA 510(k) clearance on 2025-12-03 under 510(k) number K250725. The device is classified under product code SCV. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Hugo™ RAS System?

Hugo™ RAS System is a medical device that received FDA 510(k) clearance on 2025-12-03. The listed applicant is Covidien, LLC. The 510(k) number is K250725.

When did Hugo™ RAS System receive FDA 510(k) clearance?

Hugo™ RAS System received FDA 510(k) clearance on 2025-12-03, under 510(k) number K250725.

Who is the listed applicant for Hugo™ RAS System?

FDA 510(k)记录中列出Covidien, LLC为申请人。这本身并不能确立该设备制造商的身份。

What is the FDA product code for Hugo™ RAS System?

The FDA product code for Hugo™ RAS System is SCV.

列明Covidien, 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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