ClearPoint System and Accessories
K-Number: K200079 · 2020-02-13
ApplicantMri Interventions, Inc.
Decision Date2020-02-13
Product CodeHAW
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
ClearPoint System and Accessories is a medical device manufactured by Mri Interventions, Inc.. It received FDA 510(k) clearance on 2020-02-13 under approval number K200079. 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 and Accessories?
ClearPoint System and Accessories is a medical device that received FDA 510(k) clearance on 2020-02-13. It is manufactured by Mri Interventions, Inc.. The 510(k) number is K200079.
When was ClearPoint System and Accessories approved by the FDA?
ClearPoint System and Accessories received FDA 510(k) clearance on 2020-02-13, under approval number K200079.
What company makes ClearPoint System and Accessories?
ClearPoint System and Accessories is manufactured by Mri Interventions, Inc..
What is the FDA product code for ClearPoint System and Accessories?
The FDA product code for ClearPoint System and Accessories is HAW.
Related Clinical Trials
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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.