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FDA 510(k)

ClearPoint Maestro Brain Model

K-Number: K213645 · 2022-08-08

ApplicantClearPoint Neuro, Inc.
Decision Date2022-08-08
Product CodeQIH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ClearPoint Maestro Brain Model is a medical device manufactured by ClearPoint Neuro, Inc.. It received FDA 510(k) clearance on 2022-08-08 under approval number K213645. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ClearPoint Maestro Brain Model?

ClearPoint Maestro Brain Model is a medical device that received FDA 510(k) clearance on 2022-08-08. It is manufactured by ClearPoint Neuro, Inc.. The 510(k) number is K213645.

When was ClearPoint Maestro Brain Model approved by the FDA?

ClearPoint Maestro Brain Model received FDA 510(k) clearance on 2022-08-08, under approval number K213645.

What company makes ClearPoint Maestro Brain Model?

ClearPoint Maestro Brain Model is manufactured by ClearPoint Neuro, Inc..

What is the FDA product code for ClearPoint Maestro Brain Model?

The FDA product code for ClearPoint Maestro Brain Model is QIH.

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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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