FDA 510(k)

一次性内镜注射针

K号: K252021 · 2025-12-02

申请人Changzhou New Med Micro-Medtech Co., Ltd.

决定日期2025-12-02

产品代码FBK

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 Endoscopic Injection Needles is the device name listed in this FDA 510(k) record. The listed applicant is Changzhou New Med Micro-Medtech Co., Ltd.. It received FDA 510(k) clearance on 2025-12-02 under 510(k) number K252021. The device is classified under product code FBK. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Disposable Endoscopic Injection Needles?

Disposable Endoscopic Injection Needles is a medical device that received FDA 510(k) clearance on 2025-12-02. The listed applicant is Changzhou New Med Micro-Medtech Co., Ltd.. The 510(k) number is K252021.

When did Disposable Endoscopic Injection Needles receive FDA 510(k) clearance?

Disposable Endoscopic Injection Needles received FDA 510(k) clearance on 2025-12-02, under 510(k) number K252021.

Who is the listed applicant for Disposable Endoscopic Injection Needles?

The FDA 510(k) record lists Changzhou New Med Micro-Medtech Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Disposable Endoscopic Injection Needles?

The FDA product code for Disposable Endoscopic Injection Needles is FBK.

相关器械（代码：FBK）

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器械摘要

常见问题

相关临床试验

相关器械（代码：FBK）

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