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FDA 510(k)

ClearPoint System

K-Number: K171257 · 2017-10-20

ApplicantMri Interventions, Inc.
Decision Date2017-10-20
Product CodeORR
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

ClearPoint System is a medical device manufactured by Mri Interventions, Inc.. It received FDA 510(k) clearance on 2017-10-20 under approval number K171257. The device is classified under product code ORR. 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 2017-10-20. It is manufactured by Mri Interventions, Inc.. The 510(k) number is K171257.

When was ClearPoint System approved by the FDA?

ClearPoint System received FDA 510(k) clearance on 2017-10-20, under approval number K171257.

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 ORR.

Other Devices by Mri Interventions, Inc.

K160129MRII Cranial Drill and Accessories K160434ClearPoint System K181731MR Compatible Aspiration Kit K181195ClearPoint System K191701Arcus Head Fixation Frame K191400Voyager Trajectory Array Guide (V-TAG)

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Related Devices (Code: ORR)

K181195ClearPoint SystemMri Interventions, Inc.

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.

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