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

    Isolator Synergy EnCapture Ablation System (EMH)

    K Number: K234151 · Decision Aug 27, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    30
    Registration Numbers
    30
    Same Product Code
    52
    Applicant Total
    4
    Review Days
    242

    Basic Information

    Device Name
    Isolator Synergy EnCapture Ablation System (EMH)
    K Number
    K234151
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4400
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    AtriCure Inc.
    Date Received
    December 29, 2023
    Decision Date
    August 27, 2024
    Product Code
    OCL
    Advisory Committee
    General, Plastic Surgery
    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
    OCL Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue

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    Other Clearances by AtriCure Inc.

    K Number Device Name
    K210477 AtriCure Isolator Encompass Ablation System, GLIDEPATH Magnetic GUIDE
    K200697 AtriCure cryoICE cryo-ablation probe (Cryo2), AAtriCure cryoICE cryoSPHERE cryoablation probe (CryoS, CryoS-L)
    K163408 Isolator Multifunctional Linear Pen