BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    Eversense 365 Continuous Glucose Monitoring (CGM) System

    K Number: K241335 · Decision Sep 16, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    1
    Applicant Total
    2
    Review Days
    126

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    Basic Information

    Device Name
    Eversense 365 Continuous Glucose Monitoring (CGM) System
    K Number
    K241335
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1357
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Senseonics, Incorporated
    Date Received
    May 13, 2024
    Decision Date
    September 16, 2024
    Product Code
    SBA
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    CH
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    SBA Integrated Continuous Glucose Monitoring System With Sensor Containing Dexamethasone Acetate

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (SBA), ordered by most recent decision date.

    Eversense AP CGM System

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry
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    Other Clearances by Senseonics, Incorporated

    K Number Device Name
    DEN230052 Eversense AP CGM System