Utepreva子宫内膜取样器（UP01）
K号: K240595 · 2024-08-14
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决定日期2024-08-14
产品代码HFE
咨询委员会OB
请注意，由于您没有提供具体的医疗设备监管文本，我无法进行翻译。请提供具体的文本内容，以便我能够按照您的要求进行翻译。
决定实质等同
器械摘要
Utepreva Endometrial Sampler (UP01) is the device name listed in this FDA 510(k) record. The listed applicant is Utepreva, LLC. It received FDA 510(k) clearance on 2024-08-14 under 510(k) number K240595. The device is classified under product code HFE. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Utepreva Endometrial Sampler (UP01)?
Utepreva Endometrial Sampler (UP01) is a medical device that received FDA 510(k) clearance on 2024-08-14. The listed applicant is Utepreva, LLC. The 510(k) number is K240595.
When did Utepreva Endometrial Sampler (UP01) receive FDA 510(k) clearance?
Utepreva Endometrial Sampler (UP01) received FDA 510(k) clearance on 2024-08-14, under 510(k) number K240595.
Who is the listed applicant for Utepreva Endometrial Sampler (UP01)?
The FDA 510(k) record lists Utepreva, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Utepreva Endometrial Sampler (UP01)?
The FDA product code for Utepreva Endometrial Sampler (UP01) is HFE.
相关临床试验
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相关器械（代码：HFE）
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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