Eversense 365 Continuous Glucose Monitoring (CGM) System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K241335 FDA 510(k)
- FDA Product Code
- SBA FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 862.1357 FDA 510(k)
- Regulation Number
- 862.1357 FDA 510(k)
- Advisory Committee
- Clinical Chemistry FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Eversense 365 Continuous Glucose Monitoring (CGM) System is an integrated continuous glucose monitoring system with a sensor containing dexamethasone acetate. It is indicated for continually measuring glucose levels for up to one year in people 18 years and older with diabetes.
The device is supplied as a long-term implantable CGM system and is authorized under FDA 510(k) clearance (K241335). It is classified as a Class II medical device under regulation number 862.1357 with product code SBA and is intended for use in clinical chemistry settings.
Frequently asked questions
What is the Eversense 365 CGM System used for?
The Eversense 365 Continuous Glucose Monitoring System is indicated for continually measuring glucose levels for up to one year in people 18 years and older with diabetes, providing long-term glucose tracking through an implantable sensor containing dexamethasone acetate.
How is the Eversense 365 CGM System supplied and what is its duration of use?
The device is supplied as a long-term implantable CGM system designed for continuous glucose measurement over a period of up to one year, requiring implantation and replacement annually under clinical supervision.
Is the Eversense 365 CGM System sterile and intended for single use?
The Eversense 365 CGM System sensor is supplied sterile and is intended for single-use implantation; after up to one year of use, the sensor must be explanted and replaced with a new sterile unit, as reuse is not permitted.
What regulatory pathway was used for the Eversense 365 CGM System?
The Eversense 365 Continuous Glucose Monitoring System received authorization through the FDA 510(k) clearance process under submission K241335, demonstrating substantial equivalence to a predicate device.
What are the key classifications and identifiers for the Eversense 365 CGM System?
The device is classified as a Class II medical device under regulation 862.1357 with product code SBA, and is categorized under the medical specialty of Clinical Chemistry, as reflected in its FDA 510(k) authorization details.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Eversense Continuous Glucose Monitoring (CGM) Device | Glucose ..., PDF Eversense 365 Launches in the US: One Year. One CGM., Eversense CGM System | Long-Term Implantable CGM | Global, Senseonics Announces First Commercial Patients Using Eversense 365 ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K241335 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Senseonics, Incorporated
Sources (1)
- FDA 510(k) K241335 24 fields · synced Sep 27, 2026