FDA 510(k)

HandX™ 单极剪刀

K号: K230491 · 2023-05-10

决定日期2023-05-10

产品代码GCJ

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

HandX™ Monopolar Scissors is the device name listed in this FDA 510(k) record. The listed applicant is Human Xtensions , Ltd.. It received FDA 510(k) clearance on 2023-05-10 under 510(k) number K230491. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the HandX™ Monopolar Scissors?

HandX™ Monopolar Scissors is a medical device that received FDA 510(k) clearance on 2023-05-10. The listed applicant is Human Xtensions , Ltd.. The 510(k) number is K230491.

When did HandX™ Monopolar Scissors receive FDA 510(k) clearance?

HandX™ Monopolar Scissors received FDA 510(k) clearance on 2023-05-10, under 510(k) number K230491.

Who is the listed applicant for HandX™ Monopolar Scissors?

The FDA 510(k) record lists Human Xtensions , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HandX™ Monopolar Scissors?

The FDA product code for HandX™ Monopolar Scissors is GCJ.

列明Human Xtensions , 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。

K223718HandX™ 自复位针持 K222011HandX仪器 - 单极铲 K212214HandX K203603单极钩

相关器械（代码：GCJ）

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。

K262397CuratOR EX2742Eizo Corporation K260884UNIDRIVE选择系统Karl Storz SE & CO. KG K260972OEV-271MUH 液晶显示器；OEV-321MUH 液晶显示器；OEV-431MUH 液晶显示器Sony Corporation K261139VereSee（VER150、VER200、VER151、VER201、VER200C和VER-100-103）Freyja Healthcare, LLC K253541EZ-Close™（EZ Close 端口部位闭合装置，EZ Close MAX 端口部位闭合装置，EZ Close II 端口部位闭合装置）Medical Impact K261614LED液晶显示器（OEV-271H）Lg Electronics.Inc

官方来源

在 FDA 数据库中查看 →

数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。