SBA

Integrated Continuous Glucose Monitoring System With Sensor Containing Dexamethasone Acetate

Product code

SBA

Device name

Integrated Continuous Glucose Monitoring System With Sensor Containing Dexamethasone Acetate

Device class

Class 2

21 CFR

21 CFR 862.1357

Medical specialty

Clinical Chemistry

Marketing pathway

510(K)

Flag

Implant

510(k) clearances (last 3 years)

2

Summaries archived here

1 (direct download)

510(k) clearances (all years, FDA)

2 (all years; only the last 3 years are listed here)

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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (2)

Last three years. Most recent: 2024-09-16.

1 summaries are archived here for direct download.