DeviceClearance

Product code GWG— Neurology

Aurora Surgiscope System

Classification name
Endoscope, Neurological
Device class
Class 2
Regulation
21 CFR 882.1480
Advisory panel
Neurology
Total cleared
93
First cleared
Most recent

FDA classification definition

“If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).”

— U.S. Food and Drug Administration, device classification record for product code GWG under 21 CFR 882.1480, via openFDA

Market context for product code GWG

FDA has cleared 93 devices under product code GWG between 1992 and 2026, filed by 39 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

last 15 years

Top applicants under product code GWG

Adverse events under product code GWG

product code GWG
Death
5
Total
5

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recent clearances under product code GWG

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