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

    AtriCure Isolator Encompass Ablation System, GLIDEPATH Magnetic GUIDE

    K Number: K210477 · Decision Jul 26, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    29
    Registration Numbers
    29
    Same Product Code
    53
    Applicant Total
    59
    Review Days
    157

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    Basic Information

    Device Name
    AtriCure Isolator Encompass Ablation System, GLIDEPATH Magnetic GUIDE
    K Number
    K210477
    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
    February 19, 2021
    Decision Date
    July 26, 2021
    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
    K252056 Isolator® Synergy™ EnCompass Clamp and Guide system (OLH, OSH, GPM100)
    K250371 cryoICE cryoXT cryoablation probe (cryoXT)
    K243860 AtriClip PRO-Mini LAA Exclusion System (PROM)
    K243157 AtriCure cryoICE BOX (ACM)
    K234151 Isolator Synergy EnCapture Ablation System (EMH)
    K234125 AtriClip FLEX-Mini LAA Exclusion System (ACHM)
    K233959 EPi-Ease Epicardial Access Device (EAS)
    K233407 AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (LAA0); AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (ACH1); AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (ACH2); AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (PRO1); AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (PRO2); AtriClip PRO-V LAA Exclusion System (PROV); AtriClip Flex-V LAA Exclusion System with preloaded V Clip (ACHV)
    K233170 cryoICE cryoSPHERE+ Cryoablation Probe (CRYOSP); cryoICE cryoSPHERE+ Cryoablation Probe (CRYOSP-L); cryoICE cryoSPHERE MAX Cryoablation Probe (CRYOSMAX); cryoICE cryoSPHERE MAX Cryoablation Probe (CRYOSMAX-L)
    K221358 Isolator® Linear Pen (MLP1); Isolator® Transpolar™ Pen (MAX1, MAX5), Coolrail® Linear Pen (MCR1); Isolator® Synergy Surgical Ablation System (EMR2, EML2); Isolator® Synergy™ EnCompass Clamp (OLH, OSH) and Guide System; Isolator® Synergy Access Clamp (EMT1)
    Search all 59 clearances from AtriCure, Inc. →