Digital ClarusScope System, Digital NeuroPEN System— 510(k) K223615
Substantially EquivalentClarus Medical, LLC
FDA 510(k) clearance K223615 for Digital ClarusScope System, Digital NeuroPEN System, Substantially Equivalent on 2023-11-21. Applicant: Clarus Medical, LLC.
Clearance details
- Applicant
- Clarus Medical, LLC
- Product code
- Code GWG
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Plymouth, MN, US
Adverse events under product code GWG
product code GWG- Death
- 5
- Total
- 5
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.