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510(k) Data Aggregation

    K Number
    K213135
    Device Name
    Plasma Edge resection and vaporization electrodes, Plasma Edge working elements, Adaptor Plasma Edge
    Manufacturer
    Chirurgie Innovation
    Date Cleared
    2022-03-02

    (156 days)

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

    Chirurgie Innovation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Plasma Edge System single use bipolar resection electrodes are used for the ablation and hemostasis of tissues under endoscopic control, in association with endoscopic accessories. They are intended for endoscopic surgeries with saline irrigation, in the field of urology. The use of the Plasma Edge System is restricted to surgeons, specialized in urological surgery, for specific use in: - Transurethral resection of prostate (TURP) for benign prostatic hypertrophy - Transurethral incision of the prostate (TUIP) or bladder neck - Transurethral resection of bladder tumors (TURBT) - Cystodiathermy • Transurethral Vaporization of the prostate (TUVP/TVP) for benign prostatic hypertrophy, and for Transurethral Vaporization of bladder tumors. (MVVS and MVV models only)
    Device Description
    The Plasma Edge system is a manual surgical device, consisting of a single-use electrode with cable range, an active and passive working element reusable and an adaptor to an HFgenerator compatible. The electrodes consist of an active tip, two wires threaded through ceramic tubes to connect the active tip to the body of the loop, allowing the HF energy to reach the active tip. It has to be used with continuous flow irrigation of saline solution (NaCl 0,9%) that reachesthe operative site through a resectoscope. The HF energy delivered from the generator tothe electrode ionizes the gas of the saline solution, creating a plasma for the cutting, coagulation and vaporization of tissues.
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    K Number
    K163090
    Device Name
    Plasma Edge System
    Manufacturer
    Chirurgie Innovation
    Date Cleared
    2017-05-23

    (200 days)

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

    Chirurgie Innovation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Plasma Edge System single use bipolar resection electrodes are used for the ablation and hemostasis of tissues under endoscopic control, in association with endoscopic accessories. They are intended for endoscopic surgeries with saline irrigation, in the field of urology. The use of the Plasma Edge System is restricted to surgeons, specialized in urological surgery, for specific use in: · Transurethral resection of prostate (TURP) for benign prostatic hyperplasia - · Transurethral incision of the prostate (TUIP) or bladder neck - · Transurethral resection of bladder tumors (TURBT) - · Cystodiathermy · Transurethral Vaporization of the prostate (TUVP/TVP) for benign prostatic hyperplasia, and for Transurethral Vaporization of bladder tumors. (MVVS and MVV models only)
    Device Description
    The Plasma Edge system is a manual surgical device, consisting of a single-use electrode with cable range, an active and passive working element reusable and an adaptator to an HF generator compatible. The electrodes consist of an active tip, two wires threaded through ceramic tubes to connect the active tip to the body of the loop, allowing the HF energy to reach the active tip. It has to be used with continuous flow irrigation of saline solution (NaCl 0,9%) that reaches the operative site through a resectoscope. The HF energy delivered from the generator to the electrode ionizes the gas of the saline solution, creating a plasma for the cutting, coagulation and vaporization of tissues.
    Ask a Question

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