FDA 510(k)

Hydro 灌洗系统

K号: K253679 · 2026-05-08

决定日期2026-05-08

产品代码GWG

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决定实质等同

器械摘要

Hydro Irrigation System is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Instruments. It received FDA 510(k) clearance on 2026-05-08 under 510(k) number K253679. The device is classified under product code GWG. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Hydro Irrigation System?

Hydro Irrigation System is a medical device that received FDA 510(k) clearance on 2026-05-08. The listed applicant is Stryker Instruments. The 510(k) number is K253679.

When did Hydro Irrigation System receive FDA 510(k) clearance?

Hydro Irrigation System received FDA 510(k) clearance on 2026-05-08, under 510(k) number K253679.

Who is the listed applicant for Hydro Irrigation System?

FDA 510(k)记录中列出Stryker Instruments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 Hydro Irrigation System?

The FDA product code for Hydro Irrigation System is GWG.

列明Stryker Instruments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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官方来源

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