DeviceClearance

Product code ORR— Neurology

ClearPoint System

Classification name
Neurological Stereotaxic Instrument, Real-Time Intraoperative Mri
Device class
Class 2
Regulation
21 CFR 882.4560
Advisory panel
Neurology
Total cleared
4
First cleared
Most recent

FDA classification definition

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

— U.S. Food and Drug Administration, device classification record for product code ORR under 21 CFR 882.4560, via openFDA

Market context for product code ORR

FDA has cleared 4 devices under product code ORR between 2010 and 2018, filed by 3 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code ORR

Recent clearances under product code ORR

Data sourced from openFDA. This site is unofficial and independent of the FDA.