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FDA 510(k)

无菌一次性使用带/不带针的自动失效注射器

K号: K211021 · 2022-05-06

决定日期2022-05-06
产品代码FGE
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

Sterile Biliary Stone Retrieval Balloon Catheter, Retrieval Balloon / short-wire compatible is the device name listed in this FDA 510(k) record. The listed applicant is Micro-Tech (Nanjing) Co., Ltd.. It received FDA 510(k) clearance on 2022-05-06 under 510(k) number K211021. The device is classified under product code FGE. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Sterile Biliary Stone Retrieval Balloon Catheter, Retrieval Balloon / short-wire compatible?

Sterile Biliary Stone Retrieval Balloon Catheter, Retrieval Balloon / short-wire compatible is a medical device that received FDA 510(k) clearance on 2022-05-06. The listed applicant is Micro-Tech (Nanjing) Co., Ltd.. The 510(k) number is K211021.

When did Sterile Biliary Stone Retrieval Balloon Catheter, Retrieval Balloon / short-wire compatible receive FDA 510(k) clearance?

Sterile Biliary Stone Retrieval Balloon Catheter, Retrieval Balloon / short-wire compatible received FDA 510(k) clearance on 2022-05-06, under 510(k) number K211021.

Who is the listed applicant for Sterile Biliary Stone Retrieval Balloon Catheter, Retrieval Balloon / short-wire compatible?

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

What is the FDA product code for Sterile Biliary Stone Retrieval Balloon Catheter, Retrieval Balloon / short-wire compatible?

The FDA product code for Sterile Biliary Stone Retrieval Balloon Catheter, Retrieval Balloon / short-wire compatible is FGE.

相关临床试验

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列明Micro-Tech (Nanjing) 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。

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相关器械(代码:FGE)

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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