K232618
- 510(k) number
- K232618
- Device name
- Aurora Surgiscope System
- Applicant
- Rebound Therapeutics Corporation CA · US
- Product code
- GWG — Endoscope, Neurological
- Decision date
- 2023-10-27
- Date received
- 2023-08-29
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K232618.pdf
Official FDA record: K232618
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.