ClearPoint System

Q: When was ClearPoint System cleared by the FDA?

ClearPoint System (K181195) received a 510(k) decision of Substantially Equivalent on November 2, 2018, 182 days after the submission was received.

Q: What is the product code of K181195?

The FDA product code is ORR – Neurological Stereotaxic Instrument, Real-Time Intraoperative Mri, a Class II (moderate risk) device regulated under 21 CFR 882.4560.

FDA 510(k) K181195 · Mri Interventions, Inc.

Substantially Equivalent

510(k) numberK181195

Submission

Device name: ClearPoint System
Applicant: Mri Interventions, Inc.
Irvine, CA, US
Received: May 4, 2018
Decision date: November 2, 2018
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: ORR – Neurological Stereotaxic Instrument, Real-Time Intraoperative Mri
Device class: Class II (moderate risk)
Regulation: 21 CFR 882.4560
Specialty: Neurology

To aid the surgeon in planning and conducting general stereotactic neurosurgery in an MRI suite.

Other 510(k)s with product code ORR

510(k)	Device	Applicant	Decision
K171257	ClearPoint SystemORR · Traditional	Mri Interventions, Inc.	10/20/2017SE
K111073	Surgivision Inc. Clearpoint SystemORR · Traditional	Surgi-Vision, Inc.	06/22/2011SE
K100836	Clearpoint SystemORR · Traditional	Surgivision, Inc.	06/16/2010SE

More from Surgivision, Inc.

510(k)	Device	Decision
K200079	ClearPoint System and AccessoriesHAW · Special	02/13/2020SE
K191701	Arcus Head Fixation FrameHBL · Traditional	11/15/2019SE
K191400	Voyager Trajectory Array Guide (V-TAG)HAW · Special	06/21/2019SE
K181731	MR Compatible Aspiration KitGWG · Traditional	11/20/2018SE
K171257	ClearPoint SystemORR · Traditional	10/20/2017SE
K160129	MRII Cranial Drill and AccessoriesHBG · Special	03/26/2016SE
K160434	ClearPoint SystemHAW · Special	03/17/2016SE
K142505	ClearPoint SystemHAW · Traditional	10/21/2015SE
K151536	SmartTwist MRII Hand Drill, SmartTip MRII Drill bit Kit, 4.5mm, 6.0mmHBG · Special	07/08/2015SE
K132436	Varioguide Drill KitHBE · Traditional	03/20/2014SE

Questions and answers

When was ClearPoint System cleared by the FDA?

ClearPoint System (K181195) received a 510(k) decision of Substantially Equivalent on November 2, 2018, 182 days after the submission was received.

What is the product code of K181195?

The FDA product code is ORR – Neurological Stereotaxic Instrument, Real-Time Intraoperative Mri, a Class II (moderate risk) device regulated under 21 CFR 882.4560.