Product code SBA— Clinical Chemistry
Eversense 365 Continuous Glucose Monitoring (CGM) System
- Classification name
- Integrated Continuous Glucose Monitoring System With Sensor Containing Dexamethasone Acetate
- Device class
- Class 2
- Regulation
- 21 CFR 862.1357
- Advisory panel
- Clinical Chemistry
- Total cleared
- 2
- First cleared
- Most recent
FDA classification definition
“An integrated continuous glucose monitoring system (iCGM) with sensor containing dexamethasone acetate is intended to automatically measure glucose in bodily fluids continuously or frequently for a specified period of time. iCGM systems are designed to reliably and securely transmit glucose measurement data to digitally connected devices, including automated insulin dosing systems, and are intended to be used alone or in conjunction with these digitally connected medical devices for the purpose of managing a disease or condition related to glycemic control. The dexamethasone acetate coating is intended to reduce inflammation at the sensor insertion site.”
Market context for product code SBA
FDA has cleared devices under product code SBA, all in 2024, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Top applicants under product code SBA
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 →
Recent clearances under product code SBA
Data sourced from openFDA. This site is unofficial and independent of the FDA.