FDA 510(k)

CrossGlide ETS Plus

K号: K201952 · 2020-08-05

决定日期2020-08-05

产品代码HHK

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决定实质等同

器械摘要

CrossGlide ETS Plus is the device name listed in this FDA 510(k) record. The listed applicant is Crossbay Medical. It received FDA 510(k) clearance on 2020-08-05 under 510(k) number K201952. The device is classified under product code HHK. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the CrossGlide ETS Plus?

CrossGlide ETS Plus is a medical device that received FDA 510(k) clearance on 2020-08-05. The listed applicant is Crossbay Medical. The 510(k) number is K201952.

When did CrossGlide ETS Plus receive FDA 510(k) clearance?

CrossGlide ETS Plus received FDA 510(k) clearance on 2020-08-05, under 510(k) number K201952.

Who is the listed applicant for CrossGlide ETS Plus?

The FDA 510(k) record lists Crossbay Medical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CrossGlide ETS Plus?

The FDA product code for CrossGlide ETS Plus is HHK.

列明Crossbay Medical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。

K192534CrossBay 子宫内膜组织采样器（ETS）K190813CrossBay 颈管扩张器导管系统

官方来源

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