510(k) K241335
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 16, 2024
- Date Received
- May 13, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Integrated Continuous Glucose Monitoring System With Sensor Containing Dexamethasone Acetate
- Device Class
- Class II
- Regulation Number
- 862.1357
- Review Panel
- CH
- Submission Type
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.