Digital ClarusScope System and Digital NeuroPEN System— 510(k) K252790
Substantially EquivalentClarus Medical, LLC
FDA 510(k) clearance K252790 for Digital ClarusScope System and Digital NeuroPEN System, Substantially Equivalent on 2026-05-26. Applicant: Clarus Medical, LLC. Device class: 2.
Summary
Clarus Medical's record covers two items, the Digital ClarusScope System and the Digital NeuroPEN System. The record lists one product code for both: HRX, arthroscopes.
Class II, 21 CFR 888.1100. Orthopedic is both the classification panel and the review panel. It was a Traditional 510(k).
Clarus filed from Minneapolis, Minnesota. Review took 266 calendar days (September 2, 2025 to May 26, 2026).
Clearance details
- Applicant
- Clarus Medical, LLC
- Product code
- Product code HRX
- Device class
- Class 2
- Regulation
- 21 CFR 888.1100
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Minneapolis, MN, US
Recent devices under product code HRX
view allMore clearances from Clarus Medical, LLC
view allAdverse events under product code HRX
product code HRX- Injury
- 623
- Malfunction
- 11,257
- Total
- 11,880
Source: openFDA MAUDE database, through . 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.