FDA 510(k)

Navient 图像引导导航系统 (ENT) (955-NC-NC)

K号: K243053 · 2025-06-20

决定日期2025-06-20

产品代码PGW

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决定实质等同

器械摘要

Navient Image Guided Navigation System (ENT) (955-NC-NC) is the device name listed in this FDA 510(k) record. The listed applicant is Claronav. It received FDA 510(k) clearance on 2025-06-20 under 510(k) number K243053. 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 Navient Image Guided Navigation System (ENT) (955-NC-NC)?

Navient Image Guided Navigation System (ENT) (955-NC-NC) is a medical device that received FDA 510(k) clearance on 2025-06-20. The listed applicant is Claronav. The 510(k) number is K243053.

When did Navient Image Guided Navigation System (ENT) (955-NC-NC) receive FDA 510(k) clearance?

Navient Image Guided Navigation System (ENT) (955-NC-NC) received FDA 510(k) clearance on 2025-06-20, under 510(k) number K243053.

Who is the listed applicant for Navient Image Guided Navigation System (ENT) (955-NC-NC)?

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

What is the FDA product code for Navient Image Guided Navigation System (ENT) (955-NC-NC)?

The FDA product code for Navient Image Guided Navigation System (ENT) (955-NC-NC) is PGW.

列明Claronav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。

K241327Navient 图像引导导航系统 (955-NC-NC)，颅部

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.K231862TruDi® 导航系统 V3（FG-2000-00）Acclarent, Inc.K223734ENT EMBrainlab AG K221037TruDi 剃须刀Acclarent, Inc.

官方来源

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