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

    ATRICURE DISSECTOR

    K Number: K111020 · Decision Jun 9, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    60
    Registration Numbers
    60
    Same Product Code
    28
    Applicant Total
    59
    Review Days
    58

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    Basic Information

    Device Name
    ATRICURE DISSECTOR
    K Number
    K111020
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    878.4580
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    AtriCure, Inc.
    Date Received
    April 12, 2011
    Decision Date
    June 9, 2011
    Product Code
    FTD
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    FTD Lamp, Surgical

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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. →