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FDA 510(k)

可重复使用单极主动电缆

K号: K192518 · 2019-10-25

申请人Us Endoscopy
决定日期2019-10-25
产品代码GEI
咨询委员会SU 请注意,您提供的文本“SU”不足以进行翻译。请提供完整的描述性文本以便进行翻译。
决定实质等同

器械摘要

Reusable Monopolar Active Cord is the device name listed in this FDA 510(k) record. The listed applicant is Us Endoscopy. It received FDA 510(k) clearance on 2019-10-25 under 510(k) number K192518. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Reusable Monopolar Active Cord?

Reusable Monopolar Active Cord is a medical device that received FDA 510(k) clearance on 2019-10-25. The listed applicant is Us Endoscopy. The 510(k) number is K192518.

When did Reusable Monopolar Active Cord receive FDA 510(k) clearance?

Reusable Monopolar Active Cord received FDA 510(k) clearance on 2019-10-25, under 510(k) number K192518.

Who is the listed applicant for Reusable Monopolar Active Cord?

The FDA 510(k) record lists Us Endoscopy as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Reusable Monopolar Active Cord?

The FDA product code for Reusable Monopolar Active Cord is GEI.

相关临床试验

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。

相关器械(代码:GEI)

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。

官方来源

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