FDA 510(k)

一次性输尿管通道鞘

K号: K230748 · 2023-08-02

决定日期2023-08-02

产品代码FED

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决定实质等同

器械摘要

Disposable Ureteral Access Sheath is the device name listed in this FDA 510(k) record. The listed applicant is Youcare Technology Co.,Ltd. (Wuhan). It received FDA 510(k) clearance on 2023-08-02 under 510(k) number K230748. The device is classified under product code FED. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

什么是一次性输尿管通道鞘？

Disposable Ureteral Access Sheath is a medical device that received FDA 510(k) clearance on 2023-08-02. The listed applicant is Youcare Technology Co.,Ltd. (Wuhan). The 510(k) number is K230748.

何时获得了一次性输尿管通道套管的FDA 510(k)批准？

Disposable Ureteral Access Sheath received FDA 510(k) clearance on 2023-08-02, under 510(k) number K230748.

谁是被列为一次性输尿管通道套管的申请人？

The FDA 510(k) record lists Youcare Technology Co.,Ltd. (Wuhan) as the applicant. This does not by itself establish the device manufacturer.

什么是一次性输尿管通道套管的FDA产品代码？

FDA产品代码为一次性输尿管通道套管的为FED。

列明Youcare Technology Co.,Ltd. (Wuhan)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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