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FDA 510(k)

ClearPoint System

K-Number: K181195 · 2018-11-02

ApplicantMri Interventions, Inc.
Decision Date2018-11-02
Product CodeORR
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 2018-11-02 under 510(k) number K181195. 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 2018-11-02. The listed applicant is Mri Interventions, Inc.. The 510(k) number is K181195.

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

ClearPoint System received FDA 510(k) clearance on 2018-11-02, under 510(k) number K181195.

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 ORR.

Other records listing Mri Interventions, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K200079ClearPoint System and AccessoriesK191701Arcus Head Fixation FrameK191400Voyager Trajectory Array Guide (V-TAG)K181731MR Compatible Aspiration KitK171257ClearPoint SystemK160129MRII Cranial Drill and Accessories

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Related Devices (Code: ORR)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K171257ClearPoint 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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