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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 the device name listed in this FDA 510(k) record. The listed applicant is ClearPoint Neuro, Inc.. It received FDA 510(k) clearance on 2022-08-08 under 510(k) 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. The listed applicant is ClearPoint Neuro, Inc.. The 510(k) number is K213645.

When did ClearPoint Maestro Brain Model receive FDA 510(k) clearance?

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

Who is the listed applicant for ClearPoint Maestro Brain Model?

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 Maestro Brain Model?

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

Other records listing ClearPoint Neuro, Inc. as applicant

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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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