Eversense 365 Continuous Glucose Monitoring (CGM) System
FDA 510(k) clearance K241335 · decided 2024-09-16
Clearance details
- K-number
- K241335
- Device name
- Eversense 365 Continuous Glucose Monitoring (CGM) System
- Applicant
- Senseonics, Incorporated
- Decision
- Substantially Equivalent
- Date received
- 2024-05-13
- Decision date
- 2024-09-16
- Days to decision
- 126 days
- Clearance type
- Traditional
- Product code
- SBA
- Device class
- 2
- Regulation number
- 862.1357
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Germantown, MD, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Eversense AP CGM System (DEN230052) | Senseonics, Incorporated | 2024-04-29 |
Recalls involving this device
No recalls on record reference this clearance.