510(k) DEN230052

Clearance Details

Decision

DENG (De Novo Granted)

Decision Date

April 29, 2024

Date Received

August 9, 2023

Clearance Type

Direct

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.