FDA 510(k)

Canady Flex RoboWrist

K号: K212736 · 2022-11-22

决定日期2022-11-22

产品代码GCJ

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决定实质等同

器械摘要

Canady Flex RoboWrist is the device name listed in this FDA 510(k) record. The listed applicant is Us Medical Innovations, LLC. It received FDA 510(k) clearance on 2022-11-22 under 510(k) number K212736. 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 Canady Flex RoboWrist?

Canady Flex RoboWrist is a medical device that received FDA 510(k) clearance on 2022-11-22. The listed applicant is Us Medical Innovations, LLC. The 510(k) number is K212736.

When did Canady Flex RoboWrist receive FDA 510(k) clearance?

Canady Flex RoboWrist received FDA 510(k) clearance on 2022-11-22, under 510(k) number K212736.

Who is the listed applicant for Canady Flex RoboWrist?

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

What is the FDA product code for Canady Flex RoboWrist?

The FDA product code for Canady Flex RoboWrist is GCJ.

列明Us Medical Innovations, LLC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。

K240297Canady Helios 冷等离子体™ XL-1000CP™ 消融系统 (XL-1000CPSYS)K192124Canady Plasma SMART XL-1000 电外科发生器及附件

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

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