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

    EPI-SENSE GUIDED COAGULATION DEVICE WITH VISITRAX

    K Number: K120857 · Decision Nov 13, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    29
    Registration Numbers
    29
    Same Product Code
    53
    Applicant Total
    7
    Review Days
    237

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    Basic Information

    Device Name
    EPI-SENSE GUIDED COAGULATION DEVICE WITH VISITRAX
    K Number
    K120857
    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
    Ncontact Surgical, Inc.
    Date Received
    March 21, 2012
    Decision Date
    November 13, 2012
    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 Ncontact Surgical, Inc.

    K Number Device Name
    K142084 EPI-SENSE GUIDED COAGULATION DEVICE WITH VISITRAX
    K090202 NUMERIS GUIDED COAGULATION SYSTEM WITH VISITRAX, MODELS CSK-121, -122, -123 AND -125
    K082203 NUMERIS COAGULATION SYSTEM WITH VISITRAX, MODEL(S) CSK-021;CSK-022; CSK-023; CSK-025
    K071819 NCONTACT VISITRAX GUIDED COAGULATION SYSTEM KIT, MODELS CSK-212 AND CSK-515
    K062539 NCONTACT COAGULATION SYSTEM KIT
    K063012 NCONTACT COAGULATION SYSTEM KIT, MODEL CSK