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FDA 510(k)

ClearPoint Array System

K-Number: K202575 · 2021-01-22

ApplicantClearPoint Neuro, Inc.
Decision Date2021-01-22
Product CodeHAW
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

ClearPoint Array System is a medical device manufactured by ClearPoint Neuro, Inc.. It received FDA 510(k) clearance on 2021-01-22 under approval number K202575. 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?

ClearPoint Array System is a medical device that received FDA 510(k) clearance on 2021-01-22. It is manufactured by ClearPoint Neuro, Inc.. The 510(k) number is K202575.

When was ClearPoint Array System approved by the FDA?

ClearPoint Array System received FDA 510(k) clearance on 2021-01-22, under approval number K202575.

What company makes ClearPoint Array System?

ClearPoint Array System is manufactured by ClearPoint Neuro, Inc..

What is the FDA product code for ClearPoint Array System?

The FDA product code for ClearPoint Array System is HAW.

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Other Devices by ClearPoint Neuro, Inc.

K222519ClearPoint System K213645ClearPoint Maestro Brain Model K214040ClearPoint Array System (version 1.1) 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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