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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Mri Interventions, Inc.. It received FDA 510(k) clearance on 2016-03-17 under 510(k) 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. The listed applicant is Mri Interventions, Inc.. The 510(k) number is K160434.

When did ClearPoint System receive FDA 510(k) clearance?

ClearPoint System received FDA 510(k) clearance on 2016-03-17, under 510(k) number K160434.

Who is the listed applicant for ClearPoint System?

The FDA 510(k) record lists Mri Interventions, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ClearPoint System?

The FDA product code for ClearPoint System is HAW.

Other records listing Mri Interventions, Inc. as applicant

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Related Devices (Code: 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.

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