Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 the device name listed in this FDA 510(k) record. The listed applicant is Senseonics, Incorporated. It received FDA 510(k) clearance on 2024-09-16 under 510(k) 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. The listed applicant is Senseonics, Incorporated. The 510(k) number is K241335.

When did Eversense 365 Continuous Glucose Monitoring (CGM) System receive FDA 510(k) clearance?

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

Who is the listed applicant for Eversense 365 Continuous Glucose Monitoring (CGM) System?

The FDA 510(k) record lists Senseonics, Incorporated as the applicant. This does not by itself establish the device manufacturer.

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

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT03262415PRECISION Study: Evaluating the Accuracy of the LabPatch Continuous Glucose MonitorCOMPLETEDNCT03263494CGM Intervention in Teens and Young Adults With Type 1 Diabetes (T1D)COMPLETEDNCT04230694Continuous Glucose Monitoring of Hospitalized Patients With DiabetesCOMPLETEDNCT04261738Effects of HBO on Glucose in Patients With DMTERMINATEDNCT04386005Continuous Glucose Monitoring in At-Risk NewbornsCOMPLETEDNCT04542148Glycemic Control After Antenatal Corticosteroids in Women With Pregestational and Gestational DiabetesACTIVE_NOT_RECRUITING

Related PubMed Literature

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

PMID: 41693672Continuous Glucose Monitoring in Diabetes Care in Saudi Arabia: Addressing Performance Standards and Regulatory Gaps-Literature Review and Consensus Report.Journal of diabetes science and technology (2026)

Other records listing Senseonics, Incorporated as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

PMA P160048Continuous glucose monitor, implanted, adjunctive use

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.

↑