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FDA 510(k)

ClearPointer Optical Navigation Wand

K-Number: K233155 · 2024-01-12

Decision Date2024-01-12
Product CodeHAW
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

ClearPointer Optical Navigation Wand is a medical device manufactured by ClearPoint Neuro, Inc.. It received FDA 510(k) clearance on 2024-01-12 under approval number K233155. 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 ClearPointer Optical Navigation Wand?

ClearPointer Optical Navigation Wand is a medical device that received FDA 510(k) clearance on 2024-01-12. It is manufactured by ClearPoint Neuro, Inc.. The 510(k) number is K233155.

When was ClearPointer Optical Navigation Wand approved by the FDA?

ClearPointer Optical Navigation Wand received FDA 510(k) clearance on 2024-01-12, under approval number K233155.

What company makes ClearPointer Optical Navigation Wand?

ClearPointer Optical Navigation Wand is manufactured by ClearPoint Neuro, Inc..

What is the FDA product code for ClearPointer Optical Navigation Wand?

The FDA product code for ClearPointer Optical Navigation Wand is HAW.

Other Devices by ClearPoint Neuro, Inc.

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Related Devices (Code: HAW)

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.