K223615
- 510(k) number
- K223615
- Device name
- Digital ClarusScope System, Digital NeuroPEN System
- Applicant
- Clarus Medical, LLC MN · US
- Product code
- GWG — Endoscope, Neurological
- Decision date
- 2023-11-21
- Date received
- 2022-12-05
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 2.9 MB · U.S. public domain
Also available from FDA: K223615.pdf
Official FDA record: K223615
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.