FDA 510(k)

Scopis ENT软件，Scopis ENT软件带TGS，Scopis规划软件，电磁导航单元

K号: K221098 · 2022-07-12

决定日期2022-07-12

产品代码PGW

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决定实质等同

器械摘要

Scopis ENT Software, Scopis ENT Software with TGS, Scopis Planning Software, Electromagnetic Navigation Unit is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Corporation. It received FDA 510(k) clearance on 2022-07-12 under 510(k) number K221098. 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 Scopis ENT Software, Scopis ENT Software with TGS, Scopis Planning Software, Electromagnetic Navigation Unit?

Scopis ENT Software, Scopis ENT Software with TGS, Scopis Planning Software, Electromagnetic Navigation Unit is a medical device that received FDA 510(k) clearance on 2022-07-12. The listed applicant is Stryker Corporation. The 510(k) number is K221098.

When did Scopis ENT Software, Scopis ENT Software with TGS, Scopis Planning Software, Electromagnetic Navigation Unit receive FDA 510(k) clearance?

Scopis ENT Software, Scopis ENT Software with TGS, Scopis Planning Software, Electromagnetic Navigation Unit received FDA 510(k) clearance on 2022-07-12, under 510(k) number K221098.

Who is the listed applicant for Scopis ENT Software, Scopis ENT Software with TGS, Scopis Planning Software, Electromagnetic Navigation Unit?

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

What is the FDA product code for Scopis ENT Software, Scopis ENT Software with TGS, Scopis Planning Software, Electromagnetic Navigation Unit?

The FDA product code for Scopis ENT Software, Scopis ENT Software with TGS, Scopis Planning Software, Electromagnetic Navigation Unit is PGW.

列明Stryker Corporation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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查看所有 42 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

官方来源

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