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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 the device name listed in this FDA 510(k) record. The listed applicant is ClearPoint Neuro, Inc.. It received FDA 510(k) clearance on 2023-11-27 under 510(k) 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. The listed applicant is ClearPoint Neuro, Inc.. The 510(k) number is K233243.

When did ClearPoint System (Software Version 2.2) receive FDA 510(k) clearance?

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

Who is the listed applicant for ClearPoint System (Software Version 2.2)?

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 System (Software Version 2.2)?

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

Other records listing ClearPoint Neuro, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: HAW)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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