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FDA 510(k)

SmartFrame OR

K-Number: K233141 · 2024-01-12

ApplicantClearPoint Neuro, Inc.
Decision Date2024-01-12
Product CodeHAW
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

SmartFrame OR 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 2024-01-12 under 510(k) number K233141. 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 SmartFrame OR?

SmartFrame OR is a medical device that received FDA 510(k) clearance on 2024-01-12. The listed applicant is ClearPoint Neuro, Inc.. The 510(k) number is K233141.

When did SmartFrame OR receive FDA 510(k) clearance?

SmartFrame OR received FDA 510(k) clearance on 2024-01-12, under 510(k) number K233141.

Who is the listed applicant for SmartFrame OR?

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 SmartFrame OR?

The FDA product code for SmartFrame OR is HAW.

Other records listing ClearPoint Neuro, Inc. as applicant

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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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