ClearPoint Array System (Version 1.2)
K-Number: K232102 · 2023-09-15
ApplicantClearPoint Neuro, Inc.
Decision Date2023-09-15
Product CodeHAW
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
ClearPoint Array System (Version 1.2) is a medical device manufactured by ClearPoint Neuro, Inc.. It received FDA 510(k) clearance on 2023-09-15 under approval number K232102. 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 Array System (Version 1.2)?
ClearPoint Array System (Version 1.2) is a medical device that received FDA 510(k) clearance on 2023-09-15. It is manufactured by ClearPoint Neuro, Inc.. The 510(k) number is K232102.
When was ClearPoint Array System (Version 1.2) approved by the FDA?
ClearPoint Array System (Version 1.2) received FDA 510(k) clearance on 2023-09-15, under approval number K232102.
What company makes ClearPoint Array System (Version 1.2)?
ClearPoint Array System (Version 1.2) is manufactured by ClearPoint Neuro, Inc..
What is the FDA product code for ClearPoint Array System (Version 1.2)?
The FDA product code for ClearPoint Array System (Version 1.2) is HAW.
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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.