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510(k) Data Aggregation

    K Number
    K151976
    Device Name
    Omnitech HF Resection Electrodes, Omnitech HF Vaporization Electrode
    Manufacturer
    OMNITECH SYSTEMS, INC.
    Date Cleared
    2016-06-27

    (347 days)

    Product Code
    FAS
    Regulation Number
    876.4300
    Why did this record match?
    Applicant Name (Manufacturer) :

    OMNITECH SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    RESECTION ELECTRODES: The Omnitech HF Resection electrodes are a bipolar instrument series designed and intended for use in endoscopic urological surgical procedures involving the resection, ablation, or removal of soft tissue and where hemostasis is required. The specific urological indications in the prostate, bladder and bladder neck. The procedures for which the devices can be used are: Transurethral resection in saline (TURis). Transurethral prostatectomy, transurethral resection of the prostate (TURP), for benign prostatic hyperplasia, Transurethral incision of the prostate (TUIP) or bladder neck, Transurethral resection of bladder tumors (TURBT) and cystodiathermy. These devices are intended to be used in an irrigated environment. These devices are not intended to be used in treating cancer of the prostate. VAPORIZATION ELECTRODE: The Omnitech HF Vaporization electrode for plasma vaporization is a bipolar instrument designed and intended for use in urological surgical procedures involving vaporization, cutting, removal of soft tissue and coagulation where hemostasis is required. The specific soft tissue indications include: Use in the prostate, bladder, and bladder neck. The specific treatment indications include benign prostate hyperplasia (BPH), bladder cancer, tumors, lesions and neoplasms. The specific urological indications include Transurethral Electro vaporization (TUVP), (TVP), (TVP), (TVP), (TVP), (TUEVP) also known as Transurethral Vapor Resection of the prostate (TUVRP), Transurethral Vaporization in Saline (TUVis). These devices are intended to be used in an irrigated environment. These devices are not intended to be used in treating cancer of the prostate.
    Device Description
    Not Found
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    K Number
    K050454
    Device Name
    OMNITECH FULGURATING ELECTRODE
    Manufacturer
    OMNITECH SYSTEMS, INC.
    Date Cleared
    2005-05-27

    (94 days)

    Product Code
    FAS
    Regulation Number
    876.4300
    Why did this record match?
    Applicant Name (Manufacturer) :

    OMNITECH SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Omnitech Fulgurating Electrode Device is indicated for the resection/coagulation of the soft tissue and is intended for the use with compatible Cystoscopes and Ureteroscopes. The device will be sold as a sterile product to be used in the Urological field.
    Device Description
    Not Found
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    K Number
    K981463
    Device Name
    OMNITECH RESECTOSCOPE ROLLER ELECTRODE
    Manufacturer
    OMNITECH SYSTEMS, INC.
    Date Cleared
    1998-07-17

    (85 days)

    Product Code
    KNF
    Regulation Number
    884.4160
    Why did this record match?
    Applicant Name (Manufacturer) :

    OMNITECH SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Omnitech Resectoscope Roller Device is indicated for ablation/ coagulation of the soft tissue and is intended for the use with compatible resectoscopes. The device will be sold as a sterile product to be used in the Urological and Gynecological fields.
    Device Description
    Not Found
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    K Number
    K981464
    Device Name
    OMNITECH RESECTOSCOPE CUTTING LOOP ELECTRODE
    Manufacturer
    OMNITECH SYSTEMS, INC.
    Date Cleared
    1998-07-10

    (78 days)

    Product Code
    KNF
    Regulation Number
    884.4160
    Why did this record match?
    Applicant Name (Manufacturer) :

    OMNITECH SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Omnitech Resectoscope Cutting Loop Electrode Device is indicated for resection/ coagulation of the soft tissue and is intended for the use with compatible resection/ The device will be sold as a sterile product to be used in the Urological and Gynecological fields.
    Device Description
    Omnitech Resectoscope Cutting Loop Electrode
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    K Number
    K964365
    Device Name
    RESECTOSCOPE CUTTING LOOP ELECTRODE
    Manufacturer
    OMNITECH SYSTEMS, INC.
    Date Cleared
    1997-04-22

    (172 days)

    Product Code
    FAS
    Regulation Number
    876.4300
    Why did this record match?
    Applicant Name (Manufacturer) :

    OMNITECH SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K965093
    Device Name
    OMNITECH RESECTOSCOPE ROLLER ELECTRODE
    Manufacturer
    OMNITECH SYSTEMS, INC.
    Date Cleared
    1997-03-19

    (90 days)

    Product Code
    FAS
    Regulation Number
    876.4300
    Why did this record match?
    Applicant Name (Manufacturer) :

    OMNITECH SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question

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