K250752

Substantially Equivalent

AURORA® Surgiscope® System (ASX15/60); AURORA® Surgiscope® System (ASX15/80)

Applicant: Integra LifeSciences Corporation
Product code: GWG
Advisory panel: Neurology
Date received: 2025-03-12
Decision date: 2025-04-09
Decision: Substantially Equivalent
Clearance type: Special
Location: Princeton, NJ, US

Adverse events under product code GWG

product code GWG

Death: 5
Total: 5

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

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