Not Cleared Direct

DEN230052 - Eversense AP CGM System (FDA 510(k) Clearance)

DEN230052 · Senseonics, Incorporated · Chemistry device
Apr 2024
Decision
264d
Days
Class 2
Risk

DEN230052 is an FDA 510(k) submission for the Eversense AP CGM System. This device is classified as a Integrated Continuous Glucose Monitoring System With Sensor Containing Dexamethasone Acetate (Class II - Special Controls, product code SBA).

Submitted by Senseonics, Incorporated (Germantown, US). The FDA issued a Not Cleared (DENG) decision on April 29, 2024.

This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1357. 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..

Submission Details

510(k) Number DEN230052 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received August 09, 2023
Decision Date April 29, 2024
Days to Decision 264 days
Submission Type Direct
Review Panel Chemistry (CH)
Summary -

Device Classification

Product Code SBA - Integrated Continuous Glucose Monitoring System With Sensor Containing Dexamethasone Acetate
Device Class Class II - Special Controls
CFR Regulation 21 CFR 862.1357
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.