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510(k) Data Aggregation

    K Number
    K113475
    Device Name
    ESTECH COBRA ADHERE XL 2 SURGICAL SYSTEM
    Manufacturer
    ENDOSCOPIC TECHNOLOGIES, INC. D/B/A ESTECH
    Date Cleared
    2012-03-20

    (119 days)

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

    ENDOSCOPIC TECHNOLOGIES, INC. D/B/A ESTECH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ESTECH Cobra Adhere XL2 is intended to ablate cardiac tissue during cardiac surgery using radiofrequency (RF) energy when connected directly to the Estech Electrosurgical Unit (ESU). The ESTECH Cobra Adhere XL 2 may be used for temporary cardiac pacing, sensing, recording, and stimulation during the evaluation of cardiac arrhythmias during surgery when connected to a temporary external pacemaker or recording device.
    Device Description
    The Estech COBRA Adhere XL 2 is a sterile, single use device intended for the ablation of The Esteon CODIA Cranel to deliver RF energy to the target tissue via electrodes in the device when connected to the COBRA Electrosurgical Unit (ESU). When the COBRA Adhere XL 2 is connected to an auxiliary temporary external pacemaker or recording device it can be used to provide temporary cardiac pacing, sensing, recording, and stimulation during the evaluation of cardiac arrhythmias during surgery. The COBRA Adhere XL 2 must be disconnected from the ESU and connected to a temporary external pacemaker or recording device using the accessory cable provided.
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    K Number
    K110913
    Device Name
    ESTECH COBRA SURGICAL SYSTEM WITH THERMASHIELD ACCESSORY
    Manufacturer
    ENDOSCOPIC TECHNOLOGIES, INC. D/B/A ESTECH
    Date Cleared
    2011-09-23

    (175 days)

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

    ENDOSCOPIC TECHNOLOGIES, INC. D/B/A ESTECH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Estech Cobra Surgical System is intended for the coagulation of cardiac tissue using radiofrequency (RF) energy during cardiac surgery. The System can be used during general surgery to coagulate soft tissues. The System may also be used to coagulate blood and soft tissue to produce hemostasis.
    Device Description
    The ThermaShield is a flat, bell-shaped silicone pad that is designed to reliably fill the anatomic space between the target tissue of an RF ablation and adjacent non-target tissue. Its thickness and rounded edges provide tactile feedback to the surgeon and facilitates confidence in proper placement. The ThermaShield is primarily designed for use in open chest cardiac surgery. The addition of the ThermaShield to the ESTECH Cobra Surgical System provides a more convenient option for the physician to thermally insulate surrounding non-target tissue during RF ablations. The ThermaShield is intended to improve upon circumstances where no insulation is used or to replace the current use of a surgical glove as a thermal insulator between target and surrounding tissues.
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    K Number
    K100224
    Device Name
    ESTECH COBRA BIPOLSR II
    Manufacturer
    ENDOSCOPIC TECHNOLOGIES, INC. D/B/A ESTECH
    Date Cleared
    2010-04-07

    (71 days)

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

    ENDOSCOPIC TECHNOLOGIES, INC. D/B/A ESTECH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ESTECH Cobra Bipolar II System is intended for the coagulation of soft tissue during general surgery. The system may also be used to coagulate blood and soft tissue to produce hemostasis.
    Device Description
    The ESTECH Cobra Bipolar System is designed to guide RF energy to the target tissue via electrodes in the jaws of a surgical clamp style device. RF energy is delivered in a bipolar mode, with one jaw of the device as the ablative electrode and the other jaw as the indifferent electrode.
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    K Number
    K091542
    Device Name
    ESTECH EASYFLOW CANNULA WITH GUIDEWIRE
    Manufacturer
    ENDOSCOPIC TECHNOLOGIES, INC. D/B/A ESTECH
    Date Cleared
    2009-10-20

    (147 days)

    Product Code
    DWF
    Regulation Number
    870.4210
    Why did this record match?
    Applicant Name (Manufacturer) :

    ENDOSCOPIC TECHNOLOGIES, INC. D/B/A ESTECH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ESTECH EasyFlow Cannula with Guidewire is intended for use with cardiopulmonary bypass as an arterial return or venous drainage cannula for up to 6 hours.
    Device Description
    The ESTECH EasyFlow Cannula with Guidewire is a sterile, single-use device. The single-lumen wire reinforced polymer tube incorporates multiple perforations at the distal end to provide a diffuse flow pattern. The barbed proximal end is intended to connect into cardiopulmonary bypass tubing to provide extracorporeal circulation of the blood, most typically during stopped-heart surgical procedures. Each cannula is provided with a flexible obturator to assist with the placement and positioning of the cannula and an optional stylet which inserts into the obturator to provide additional column strength for insertion. The product also comes with a 0.035" diameter guidewire, up to 3 vessel dilators, an 18 gauge. needle, and scalpel for introduction
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    K Number
    K091350
    Device Name
    ESTECH HAWKEYE INTRODUCER SYSTEMS
    Manufacturer
    ENDOSCOPIC TECHNOLOGIES, INC. D/B/A ESTECH
    Date Cleared
    2009-09-15

    (131 days)

    Product Code
    GCJ
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    ENDOSCOPIC TECHNOLOGIES, INC. D/B/A ESTECH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Hawkeye™ Introducer Systems, and accessories, are intended for use in minimally invasive surgery allowing access for delivery and placement of surgical instruments (e.g., ESTECH COBRA Adhere XL, AFfirm Pacing Probe). They are indicated for patients requiring blunt dissection of tissue including structures in the thoracic space.
    Device Description
    The Hawkeye family consists of two products; the ESTECH Hawkeye Magnetic Introducer System and the ESTECH Hawkeye Scope System. The Hawkeye Magnetic Introducer System is comprised of three main components: - 1. Hawkeye Magnetic Cannula Assembly - 2. Magnetic Introducer - 3. Malleable Stylet Both Systems allow for endoscopic visualization within the thoracic cavity, blunt dissection, and facilitate the placement of surgical equipment. These pieces may be packaged, sterilized and sold separately. They are single-use only.
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