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FDA 510(k)

ClearPoint System (Software Version 2.2)

K-Number: K233243 · 2023-11-27

ApplicantClearPoint Neuro, Inc.
Decision Date2023-11-27
Product CodeHAW
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

ClearPoint System (Software Version 2.2) is a medical device manufactured by ClearPoint Neuro, Inc.. It received FDA 510(k) clearance on 2023-11-27 under approval number K233243. The device is classified under product code HAW. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ClearPoint System (Software Version 2.2)?

ClearPoint System (Software Version 2.2) is a medical device that received FDA 510(k) clearance on 2023-11-27. It is manufactured by ClearPoint Neuro, Inc.. The 510(k) number is K233243.

When was ClearPoint System (Software Version 2.2) approved by the FDA?

ClearPoint System (Software Version 2.2) received FDA 510(k) clearance on 2023-11-27, under approval number K233243.

What company makes ClearPoint System (Software Version 2.2)?

ClearPoint System (Software Version 2.2) is manufactured by ClearPoint Neuro, Inc..

What is the FDA product code for ClearPoint System (Software Version 2.2)?

The FDA product code for ClearPoint System (Software Version 2.2) is HAW.

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Related PubMed Literature

PMID: 42175114 Make Open Source Compliant: Validation in Non-Interventional Clinical Studies. Studies in health technology and informatics (2026) PMID: 41116086 Eye-tracking-based tablet application for enhanced cognitive assessment: a clinical trial for software as a medical device (SaMD). GeroScience (2025) PMID: 40845310 Should Digital Interventions for HIV Self-Testing Be Regulated with World Health Organization Prequalification? JMIR mHealth and uHealth (2025)

Other Devices by ClearPoint Neuro, Inc.

K202575ClearPoint Array System K222519ClearPoint System K213645ClearPoint Maestro Brain Model K214040ClearPoint Array System (version 1.1) K232102ClearPoint Array System (Version 1.2) DEN240023SmartFlow Neuro Cannula

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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