FDA 510(k)

一次性结石取出篮

K号: K253056 · 2026-04-03

申请人Zhejiang Soudon Medical Technology Co., Ltd.

决定日期2026-04-03

产品代码LQR

咨询委员会GU 请注意，由于您只提供了“GU”这个词，我无法提供完整的翻译。如果您能提供完整的句子或段落，我将能够为您提供准确的翻译。

决定实质等同

器械摘要

Disposable Stone Extraction Basket is the device name listed in this FDA 510(k) record. The listed applicant is Zhejiang Soudon Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2026-04-03 under 510(k) number K253056. The device is classified under product code LQR. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Disposable Stone Extraction Basket?

Disposable Stone Extraction Basket is a medical device that received FDA 510(k) clearance on 2026-04-03. The listed applicant is Zhejiang Soudon Medical Technology Co., Ltd.. The 510(k) number is K253056.

When did Disposable Stone Extraction Basket receive FDA 510(k) clearance?

Disposable Stone Extraction Basket received FDA 510(k) clearance on 2026-04-03, under 510(k) number K253056.

Who is the listed applicant for Disposable Stone Extraction Basket?

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

What is the FDA product code for Disposable Stone Extraction Basket?

The FDA product code for Disposable Stone Extraction Basket is LQR.

列明Zhejiang Soudon 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。

K253013一次性结石取出球囊导管 K232450一次性止血夹 K232442一次性内镜注射针 K232476一次性肛门括约肌刀

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