FDA 510(k)

Cube 导航系统，VirtuEye V2，导航传感器 NanoRest，导航单元 Cube 4D

K号: K211291 · 2021-07-19

决定日期2021-07-19

产品代码PGW

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决定实质等同

器械摘要

Cube Navigation System, VirtuEye V2, Navigation Sensor NanoRest, Navigation Unit Cube 4D is the device name listed in this FDA 510(k) record. The listed applicant is Fiagon GmbH. It received FDA 510(k) clearance on 2021-07-19 under 510(k) number K211291. The device is classified under product code PGW. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Cube Navigation System, VirtuEye V2, Navigation Sensor NanoRest, Navigation Unit Cube 4D?

Cube Navigation System, VirtuEye V2, Navigation Sensor NanoRest, Navigation Unit Cube 4D is a medical device that received FDA 510(k) clearance on 2021-07-19. The listed applicant is Fiagon GmbH. The 510(k) number is K211291.

When did Cube Navigation System, VirtuEye V2, Navigation Sensor NanoRest, Navigation Unit Cube 4D receive FDA 510(k) clearance?

Cube Navigation System, VirtuEye V2, Navigation Sensor NanoRest, Navigation Unit Cube 4D received FDA 510(k) clearance on 2021-07-19, under 510(k) number K211291.

Who is the listed applicant for Cube Navigation System, VirtuEye V2, Navigation Sensor NanoRest, Navigation Unit Cube 4D?

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

What is the FDA product code for Cube Navigation System, VirtuEye V2, Navigation Sensor NanoRest, Navigation Unit Cube 4D?

The FDA product code for Cube Navigation System, VirtuEye V2, Navigation Sensor NanoRest, Navigation Unit Cube 4D is PGW.

列明Fiagon GmbH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。

K261540Cube 4D 导航系统，VirtuEye Pro K230700RIWOtrack 导航系统 K230065VenSure™ 气球扩张系统，VenSure™ 轻型气球扩张系统，VenSure™ 导航气球扩张系统，VenSure™ ET 气球扩张系统 K201472VenSure 气球装置，VenSure 导航气球装置 K200041FlexPointer 1.5 单次使用，FlexTube 3 单次使用 K163209Fiagon 导航系统

查看所有 13 个设备 →

相关器械（代码：PGW）

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。

K262235ApexCut™ 自动电磁跟踪刀片（187BL4012EM）；ApexCut™ 自动电磁跟踪刀片（187BL4040EM）；ApexCut™ 自动电磁跟踪刀片（187BL4060EM）；ApexCut™ 自动电磁跟踪刀片（187BL2975EM）；ApexCut™ 自动电磁跟踪刀片（187BL3590EM）；ApexCut™ 自动电磁跟踪刀片（187BL4000LEM）Medtronic Xomed, Inc.K261540Cube 4D 导航系统，VirtuEye ProFiagon GmbH K253395Stealth AXiS™ ENT临床应用Medtronic Navigation, Inc.K243053Navient 图像引导导航系统 (ENT) (955-NC-NC)Claronav K231862TruDi® 导航系统 V3（FG-2000-00）Acclarent, Inc.K223734ENT EMBrainlab AG

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