FDA 510(k)

ClearPoint 系统（软件版本 3.0）

K号: K243657 · 2025-01-24

决定日期2025-01-24

产品代码HAW

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决定实质等同

器械摘要

ClearPoint System (Software Version 3.0) is the device name listed in this FDA 510(k) record. The listed applicant is ClearPoint Neuro, Inc.. It received FDA 510(k) clearance on 2025-01-24 under 510(k) number K243657. The device is classified under product code HAW. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the ClearPoint System (Software Version 3.0)?

ClearPoint System (Software Version 3.0) is a medical device that received FDA 510(k) clearance on 2025-01-24. The listed applicant is ClearPoint Neuro, Inc.. The 510(k) number is K243657.

When did ClearPoint System (Software Version 3.0) receive FDA 510(k) clearance?

ClearPoint System (Software Version 3.0) received FDA 510(k) clearance on 2025-01-24, under 510(k) number K243657.

Who is the listed applicant for ClearPoint System (Software Version 3.0)?

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

What is the FDA product code for ClearPoint System (Software Version 3.0)?

The FDA product code for ClearPoint System (Software Version 3.0) is HAW.

列明ClearPoint Neuro, Inc.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。

K233703骨锚 (NGS-BA-01)K233144ClearPoint 骨螺钉标记物 K233155ClearPointer 光学导航棒 K233141SmartFrame OR K233243ClearPoint 系统（软件版本 2.2）K232102ClearPoint Array 系统（版本 1.2）

查看所有 11 个设备 →

官方来源

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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。