Surgivision Inc. Clearpoint System

Q: What is the product code of K111073?

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) K111073 · Surgi-Vision, Inc.

Substantially Equivalent

510(k) numberK111073

Submission

Device name: Surgivision Inc. Clearpoint System
Applicant: Surgi-Vision, Inc.
Irvine, CA, US
Received: April 18, 2011
Decision date: June 22, 2011
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
K181195	ClearPoint SystemORR · Traditional	Mri Interventions, Inc.	11/02/2018SE
K171257	ClearPoint SystemORR · Traditional	Mri Interventions, Inc.	10/20/2017SE
K100836	Clearpoint SystemORR · Traditional	Surgivision, Inc.	06/16/2010SE

More from Surgivision, Inc.

510(k)	Device	Decision
K020790	Intercept Esophageal Internal MR Coil, Intercept Urethral Microcoil, and Intercept…MOS · Traditional	05/21/2002SE
K020495	Intercept Esophageal Internal MR Coil, Intercept Urethral Internal MR Coil, and…MOS · Traditional	04/23/2002SE
K011781	Intercept-Urethral MicrocoilMOS · Traditional	08/31/2001SE
K003436	Surgi-Vision Guidewire CoilMOS · Traditional	02/02/2001SE
K002916	Surgi-Vision Prostate CoilMOS · Traditional	11/28/2000SE
K002345	Surgi-Vision Urethral CoilMOS · Traditional	10/11/2000SE
K994436	Surgi-Vision Esophageal Stylet CoilMOS · Traditional	03/14/2000SE
K992193	Endo-Esophageal MR CoilMOS · Traditional	09/03/1999SE

Questions and answers

When was Surgivision Inc. Clearpoint System cleared by the FDA?

Surgivision Inc. Clearpoint System (K111073) received a 510(k) decision of Substantially Equivalent on June 22, 2011, 65 days after the submission was received.

What is the product code of K111073?

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.