K240535
- 510(k) number
- K240535
- Device name
- Digital ClarusScope System; Digital NeuroPEN System
- Applicant
- Clarus Medical, LLC MN · US
- Product code
- HRX — Arthroscope
- Decision date
- 2024-04-25
- Date received
- 2024-02-26
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 3.0 MB · U.S. public domain
Also available from FDA: K240535.pdf
Official FDA record: K240535
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.