K241335 is an FDA 510(k) clearance for the Eversense 365 Continuous Glucose Monitoring (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 Cleared decision on September 16, 2024, 126 days after receiving the submission on May 13, 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..
| 510(k) Number | K241335 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 13, 2024 |
| Decision Date | September 16, 2024 |
| Days to Decision | 126 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| 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. |