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

    esolution® Esophageal Retractor

    K Number: K243233 · Decision Nov 9, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    1
    Applicant Total
    2
    Review Days
    31

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    Basic Information

    Device Name
    esolution® Esophageal Retractor
    K Number
    K243233
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.5710
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    S4 Medical Corp.
    Date Received
    October 9, 2024
    Decision Date
    November 9, 2024
    Product Code
    QXU
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

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

    Product Code Device Name
    QXU Esophageal Protection Device For Use In Percutaneous Cardiac Catheter Ablation Procedures, Mechanical Deviation

    Similar 510(k) Clearances

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

    esolution

    FDA 510(k)
    FDA Class 2 ·Cardiovascular
    View all

    Other Clearances by S4 Medical Corp.

    K Number Device Name
    DEN230006 esolution