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FDA 510(k)

ClearPoint Array System (version 1.1)

K-Number: K214040 · 2022-04-12

ApplicantClearPoint Neuro, Inc.
Decision Date2022-04-12
Product CodeHAW
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

ClearPoint Array System (version 1.1) is a medical device manufactured by ClearPoint Neuro, Inc.. It received FDA 510(k) clearance on 2022-04-12 under approval number K214040. 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 Array System (version 1.1)?

ClearPoint Array System (version 1.1) is a medical device that received FDA 510(k) clearance on 2022-04-12. It is manufactured by ClearPoint Neuro, Inc.. The 510(k) number is K214040.

When was ClearPoint Array System (version 1.1) approved by the FDA?

ClearPoint Array System (version 1.1) received FDA 510(k) clearance on 2022-04-12, under approval number K214040.

What company makes ClearPoint Array System (version 1.1)?

ClearPoint Array System (version 1.1) is manufactured by ClearPoint Neuro, Inc..

What is the FDA product code for ClearPoint Array System (version 1.1)?

The FDA product code for ClearPoint Array System (version 1.1) is HAW.

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Other Devices by ClearPoint Neuro, Inc.

K202575ClearPoint Array System K222519ClearPoint System K213645ClearPoint Maestro Brain Model K233243ClearPoint System (Software Version 2.2) 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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