ClearPoint System
K-Number: K160434 · 2016-03-17
ApplicantMri Interventions, Inc.
Decision Date2016-03-17
Product CodeHAW
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
ClearPoint System is a medical device manufactured by Mri Interventions, Inc.. It received FDA 510(k) clearance on 2016-03-17 under approval number K160434. 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?
ClearPoint System is a medical device that received FDA 510(k) clearance on 2016-03-17. It is manufactured by Mri Interventions, Inc.. The 510(k) number is K160434.
When was ClearPoint System approved by the FDA?
ClearPoint System received FDA 510(k) clearance on 2016-03-17, under approval number K160434.
What company makes ClearPoint System?
ClearPoint System is manufactured by Mri Interventions, Inc..
What is the FDA product code for ClearPoint System?
The FDA product code for ClearPoint System 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.