CrossBay 子宫内膜组织采样器（ETS）
K号: K192534 · 2020-03-25
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决定日期2020-03-25
产品代码HHK
咨询委员会OB
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决定实质等同
器械摘要
CrossBay Endometrial Tissue Sampler (ETS) is the device name listed in this FDA 510(k) record. The listed applicant is Crossbay Medical. It received FDA 510(k) clearance on 2020-03-25 under 510(k) number K192534. 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 CrossBay Endometrial Tissue Sampler (ETS)?
CrossBay Endometrial Tissue Sampler (ETS) is a medical device that received FDA 510(k) clearance on 2020-03-25. The listed applicant is Crossbay Medical. The 510(k) number is K192534.
When did CrossBay Endometrial Tissue Sampler (ETS) receive FDA 510(k) clearance?
CrossBay Endometrial Tissue Sampler (ETS) received FDA 510(k) clearance on 2020-03-25, under 510(k) number K192534.
Who is the listed applicant for CrossBay Endometrial Tissue Sampler (ETS)?
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 CrossBay Endometrial Tissue Sampler (ETS)?
The FDA product code for CrossBay Endometrial Tissue Sampler (ETS) is HHK.
相关临床试验
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列明Crossbay Medical为申报人的其他记录
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相关器械（代码：HHK）
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。
官方来源
在 FDA 数据库中查看 →数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。
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