K250752
- 510(k) number
- K250752
- Device name
- AURORA® Surgiscope® System (ASX15/60); AURORA® Surgiscope® System (ASX15/80)
- Applicant
- Integra LifeSciences Corporation NJ · US
- Product code
- GWG — Endoscope, Neurological
- Decision date
- 2025-04-09
- Date received
- 2025-03-12
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K250752.pdf
Official FDA record: K250752
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.