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FDA 510(k)

Eversense 365 Continuous Glucose Monitoring (CGM) System

K-Number: K241335 · 2024-09-16

ApplicantSenseonics, Incorporated
Decision Date2024-09-16
Product CodeSBA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

Eversense 365 Continuous Glucose Monitoring (CGM) System is a medical device manufactured by Senseonics, Incorporated. It received FDA 510(k) clearance on 2024-09-16 under approval number K241335. The device is classified under product code SBA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Eversense 365 Continuous Glucose Monitoring (CGM) System?

Eversense 365 Continuous Glucose Monitoring (CGM) System is a medical device that received FDA 510(k) clearance on 2024-09-16. It is manufactured by Senseonics, Incorporated. The 510(k) number is K241335.

When was Eversense 365 Continuous Glucose Monitoring (CGM) System approved by the FDA?

Eversense 365 Continuous Glucose Monitoring (CGM) System received FDA 510(k) clearance on 2024-09-16, under approval number K241335.

What company makes Eversense 365 Continuous Glucose Monitoring (CGM) System?

Eversense 365 Continuous Glucose Monitoring (CGM) System is manufactured by Senseonics, Incorporated.

What is the FDA product code for Eversense 365 Continuous Glucose Monitoring (CGM) System?

The FDA product code for Eversense 365 Continuous Glucose Monitoring (CGM) System is SBA.

Related Clinical Trials

NCT07614139 Continuous Glucose Monitoring Alerts, Accuracy, and Patient Outcomes in Adults With Inherited Metabolic Disorders COMPLETED NCT07599982 Safety Evaluation of MODI, an Insulin Titration Algorithm, in Adults With Diabetes RECRUITING NCT07092761 Evaluation of the Accuracy and Safety of A Novel Real-Time Continuous Glucose Monitoring System RECRUITING NCT07499128 Continuous Temperature Monitoring (CTM) for Cytokine Release Syndrome (CRS), an Immune-Related Adverse Event ENROLLING_BY_INVITATION NCT07606495 Impact on Prognosis of Increased Sleep Quality Obtained by Personalized Night-time Nursing Care in Critically Ill Patients NOT_YET_RECRUITING NCT07614581 Intra-Sessional Autonomic Arc Detection in Ketamine-Assisted Therapy for PTSD: A Signal Characterisation Pilot Study NOT_YET_RECRUITING

Related PubMed Literature

PMID: 42174947 Aligning AI-Native 6G Healthcare Systems with EU Ethical and Legal Frameworks. Studies in health technology and informatics (2026) PMID: 41966529 Comparison of the AccuPower HIV-1 Quant Kit and Aptima HIV-1 Quant Dx Assay for quantification of HIV-1 plasma viral load. Diagnostic microbiology and infectious disease (2026) PMID: 41964171 Journal of diabetes science and technology (2026) PMID: 41760572 Trends in use of continuous glucose monitors among individuals with type 2 diabetes enrolled in Medicare Advantage (2021-2023). Journal of managed care & specialty pharmacy (2026)

Other Devices by Senseonics, Incorporated

DEN230052Eversense AP CGM System PMA P160048Continuous glucose monitor, implanted, adjunctive use

Related Devices (Code: SBA)

DEN230052Eversense AP CGM SystemSenseonics, Incorporated

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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