Clearpoint System

FDA 510(k) K100836 · Surgivision, Inc.

Substantially Equivalent

510(k) numberK100836

Submission

Device name
Clearpoint System
Applicant
Surgivision, Inc.
Washington, D.C., DC, US
Received
March 24, 2010
Decision date
June 16, 2010
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)DeviceApplicantDecision
K181195ClearPoint SystemORR · Traditional Mri Interventions, Inc.11/02/2018SE
K171257ClearPoint SystemORR · Traditional Mri Interventions, Inc.10/20/2017SE
K111073Surgivision Inc. Clearpoint SystemORR · Traditional Surgi-Vision, Inc.06/22/2011SE

More from Surgi-Vision, Inc.

510(k)DeviceDecision
K102101Surgivision MR Compatible Ventricular CannulaHCD · Traditional 01/26/2011SE
K091343MRI Neuro DrapeKKX · Traditional 09/22/2009SE
K091439Head Fixation Arc and Table BaseHBL · Traditional 08/25/2009SE

Questions and answers

When was Clearpoint System cleared by the FDA?

Clearpoint System (K100836) received a 510(k) decision of Substantially Equivalent on June 16, 2010, 84 days after the submission was received.

What is the product code of K100836?

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.