FDA 510(k)

一次性输尿管通路鞘

K号: K243710 · 2025-04-11

申请人Shenzhen Trious Medical Technology Co., Ltd.

决定日期2025-04-11

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 Shenzhen Trious Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2025-04-11 under 510(k) number K243710. The device is classified under product code FED. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Disposable ureteral access sheath?

Disposable ureteral access sheath is a medical device that received FDA 510(k) clearance on 2025-04-11. The listed applicant is Shenzhen Trious Medical Technology Co., Ltd.. The 510(k) number is K243710.

When did Disposable ureteral access sheath receive FDA 510(k) clearance?

Disposable ureteral access sheath received FDA 510(k) clearance on 2025-04-11, under 510(k) number K243710.

Who is the listed applicant for Disposable ureteral access sheath?

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

What is the FDA product code for Disposable ureteral access sheath?

The FDA product code for Disposable ureteral access sheath is FED.

列明Shenzhen Trious Medical Technology Co., Ltd.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。

K250448一次性经皮肾造口扩张套件 K243830一次性输尿管支架

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