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

    AtriCure cryoICE BOX (ACM)

    K Number: K243157 · Decision Oct 29, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    22
    Applicant Total
    19
    Review Days
    29

    Basic Information

    Device Name
    AtriCure cryoICE BOX (ACM)
    K Number
    K243157
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    882.4250
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    AtriCure, Inc.
    Date Received
    September 30, 2024
    Decision Date
    October 29, 2024
    Product Code
    GXH
    Advisory Committee
    Neurology
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    GXH Device, Surgical, Cryogenic

    Similar 510(k) Clearances

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

    cryoICE cryoXT cryoablation probe (cryoXT)

    FDA 510(k)
    FDA Class 2 ·Neurology

    iovera° System

    FDA 510(k)
    FDA Class 2 ·Neurology

    cryoICE cryoSPHERE+ Cryoablation Probe (CRYOSP); cryoICE cryoSPHERE+ Cryoablation Probe (CRYOSP-L); cryoICE cryoSPHERE MAX Cryoablation Probe (CRYOSMAX); cryoICE cryoSPHERE MAX Cryoablation Probe (CRYOSMAX-L)

    FDA 510(k)
    FDA Class 2 ·Neurology

    iovera System

    FDA 510(k)
    FDA Class 2 ·Neurology

    Iovera System

    FDA 510(k)
    FDA Class 2 ·Neurology

    AtriCure cryoICE cryo-ablation probe (Cryo2), AAtriCure cryoICE cryoSPHERE cryoablation probe (CryoS, CryoS-L)

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

    Other Clearances by AtriCure, Inc.

    K Number Device Name
    K250371 cryoICE cryoXT cryoablation probe (cryoXT)
    K243860 AtriClip PRO-Mini LAA Exclusion System (PROM)
    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)
    K211311 AtriCure Isolator® Synergy™ Surgical Ablation System
    K210293 AtriClip LAA Exclusion System
    K193162 EPi-Sense Guided Coagulation System with VisiTrax
    K190151 COBRA Fusion Ablation System
    Search all 19 clearances from AtriCure, Inc. →