LogoFDA 510(k) Search
Search Filters

Search Results

Found 2 results

510(k) Data Aggregation

    K Number
    K080202
    Device Name
    ONCOBIONIC SYSTEM WITH 6 PROBE OUTPUT
    Manufacturer
    ONCOBIONICS, INC.
    Date Cleared
    2008-05-08

    (101 days)

    Product Code
    OAB
    Regulation Number
    878.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    ONCOBIONICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Oncobionic System with 6 probe output is indicated for use for surgical ablation of soft tissue.
    Device Description
    The Oncobionic System with 6 probe output is identical in design specification to the Oncobionic System cleared under K060054. The only change to the Oncobionic System with 6 probe output is the addition of 4 output ports to allow for the connection of up to six electrodes to the Generator. This design addition has been added for convenience to the use. The user can connect multiple pairs of probes thus to removing the need to connect and disconnect pairs of electrodes when treating multiple treatment sites.
    Ask a Question
    K Number
    K060054
    Device Name
    ONCOBIONIC SYSTEM
    Manufacturer
    ONCOBIONICS, INC.
    Date Cleared
    2006-11-21

    (319 days)

    Product Code
    OAB, OCL
    Regulation Number
    878.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    ONCOBIONICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Oncobionic System is indicated for surgical ablation of soft tissue, including cardiac and smooth muscle.
    Device Description
    The Oncobionic System comprises a low energy direct current (LEDC) Generator and two Electrodes. The Oncobionic System applies a LEDC pulse or series of pulses between two electrodes to ablate tissue.
    Ask a Question

    Page 1 of 1