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 a medical device manufactured by ClearPoint Neuro, Inc.. It received FDA 510(k) clearance on 2024-01-12 under approval 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. It is manufactured by ClearPoint Neuro, Inc.. The 510(k) number is K233141.
When was SmartFrame OR approved by the FDA?
SmartFrame OR received FDA 510(k) clearance on 2024-01-12, under approval number K233141.
What company makes SmartFrame OR?
SmartFrame OR is manufactured by ClearPoint Neuro, Inc..
What is the FDA product code for SmartFrame OR?
The FDA product code for SmartFrame OR 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.