Eversense 365 Continuous Glucose Monitoring (CGM) System— 510(k) K241335
Substantially EquivalentSenseonics, Incorporated
FDA 510(k) clearance K241335 for Eversense 365 Continuous Glucose Monitoring (CGM) System, Substantially Equivalent on 2024-09-16. Applicant: Senseonics, Incorporated.
Clearance details
- Applicant
- Senseonics, Incorporated
- Product code
- Code SBA
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Germantown, MD, US
Adverse events under product code SBA
product code SBA- Injury
- 488
- Malfunction
- 1,364
- Total
- 1,852
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.