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510(k) Data Aggregation

    K Number
    K142084
    Device Name
    EPI-SENSE GUIDED COAGULATION DEVICE WITH VISITRAX
    Manufacturer
    NCONTACT SURGICAL, INC.
    Date Cleared
    2014-10-28

    (89 days)

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

    NCONTACT SURGICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The EPi-Sense Guided Coagulation System with VisiTrax is intended for the coagulation of cardiac tissue using Radiofrequency (RF) energy using thoracoscopic, endoscopic, and laparoscopic surgical techniques. The EPi-Sense Guided Coagulation System with VisiTrax may be used for temporary cardiac signal sensing and recording during surgery when connected to an external recording device.
    Device Description
    The EPi-Sense Guided Coagulation System with VisiTrax consists of a sterile, single-use, disposable coagulation electrode device (1cm, 2cm, & 3cm sizes provided) intended to be used to coagulate cardiac tissue. The flexible, cooled electrode device, with a suction stabilizer feature, transmits radiofrequency (RF) energy from an Electrosurgical Generator (non-sterile, re-useable) connected through an Instrument Cable (sterile). A temporary sensing electrode feature may be used with an off-the-shelf electrogram recording system with the use of an additional instrument cable (non-sterile). An accessory Cannula may be used to facilitate coagulation device access and visibility of the heart. The Cannula accessory changes are the subject of this submission.
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    K Number
    K120857
    Device Name
    EPI-SENSE GUIDED COAGULATION DEVICE WITH VISITRAX
    Manufacturer
    NCONTACT SURGICAL, INC.
    Date Cleared
    2012-11-13

    (237 days)

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

    NCONTACT SURGICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The EPi-Sense Guided Coagulation System with VisiTrax is intended for the coagulation of cardiac tissue using Radiofrequency (RF) energy using thoracoscopic, endoscopic, and laparoscopic surgical techniques. The EPi-Sense Guided Coagulation System with VisiTrax may be used for temporary cardiac signal sensing and recording during surgery when connected to an external recording device.
    Device Description
    The EPi-Sense Guided Coagulation System with VisiTrax - generation 4 product) consists of a sterile, single-use, disposable coagulation electrode device (1cm, 2cm, & 3cm sizes provided) intended to be used to coagulate cardiac tissue. The flexible, cooled electrode device, with a suction stabilizer feature, transmits radiofrequency (RF) energy from an Electrosurgical Generator (non-sterile, re-useable) connected through an Instrument Cable (sterile). An optional temporary sensing electrode feature may be used with . an off-the-shelf electrogram recording system with the use of an additional instrument cable (non-sterile).
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    K Number
    K090202
    Device Name
    NUMERIS GUIDED COAGULATION SYSTEM WITH VISITRAX, MODELS CSK-121, -122, -123 AND -125
    Manufacturer
    NCONTACT SURGICAL, INC.
    Date Cleared
    2009-02-17

    (21 days)

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

    NCONTACT SURGICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Numeris™ Guided Coagulation System with VisiTrax® is intended for the coagulation of cardiac tissue using Radiofrequency (RF) energy using thoracoscopic, endoscopic, and laparoscopic surgical techniques.
    Device Description
    The modified nContact Coagulation System (Numeris Guided Coaquiation System with VisiTrax) consists of a sterile, single-use, disposable coagulation electrode device (1cm, 2cm, & 5cm sizes provided) intended to be used to coagulate cardiac tissue. The flexible, cooled electrode device, with a suction stabilizer feature, transmits radiofrequency (RF) energy from an Electrosurgical Generator (non-sterile, re-useable) connected through an Instrument Cable (sterile). The functionality of this System is the same as the cleared predicate guided system, however two additional RF coil electrode lengths have been added to the product offering (1cm and 3cm).
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    K Number
    K082203
    Device Name
    NUMERIS COAGULATION SYSTEM WITH VISITRAX, MODEL(S) CSK-021;CSK-022; CSK-023; CSK-025
    Manufacturer
    NCONTACT SURGICAL, INC.
    Date Cleared
    2008-12-30

    (147 days)

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

    NCONTACT SURGICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Numeris™ Tethered Coagulation System with VisiTrax® is intended for the coagulation of cardiac tissue using Radiofrequency (RF) energy during open-chest cardiac surgery.
    Device Description
    The modified nContact system, "Numeris Tethered Coagulation System with VisiTrax", consists of a sterile, single-use, disposable coagulation electrode device (1cm, 2cm, 3cm, & 5cm sizes provided) intended to be used to coagulate cardiac tissue. The flexible, cooled electrode device, with a suction stabilizer feature, transmits radiofrequency (RF) energy from an Electrosurgical Generator (non-sterile, re-useable) connected through an Instrument Cable (sterile). The functionality of this System is the same as the cleared predicate system, however two addition RF coil electrode lengths have been added to the product offering (1cm and 3cm).
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    K Number
    K071819
    Device Name
    NCONTACT VISITRAX GUIDED COAGULATION SYSTEM KIT, MODELS CSK-212 AND CSK-515
    Manufacturer
    NCONTACT SURGICAL, INC.
    Date Cleared
    2007-07-26

    (23 days)

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

    NCONTACT SURGICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The nContact Guided Coagulation System (VisiTrax™) is intended for the coagulation of cardiac tissue using Radiofrequency (RF) energy.
    Device Description
    The nContact Guided Coagulation System (VisiTrax) consists of a sterile, single-use, disposable coagulation electrode device (2cm & 5cm sizes provided) intended to be used to coagulate cardiac tissue. The flexible, cooled electrode device, with a suction stabilizer feature, transmits radiofrequency (RF) energy from an Electrosurgical Generator (non-sterile, re-useable) connected through an Instrument Cable (sterile). The functionality of this System is the same as the cleared predicate system.
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    K Number
    K062539
    Device Name
    NCONTACT COAGULATION SYSTEM KIT
    Manufacturer
    NCONTACT SURGICAL, INC.
    Date Cleared
    2006-12-01

    (94 days)

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

    NCONTACT SURGICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The nContact Coagulation System is intended for the coagulation of soft tissue using Radiofrequency (RF) energy.
    Device Description
    The nContact Coagulation System consists of a sterile, single-use, disposable coagulation electrode device (2cm & 5cm sizes provided) intended to be used to coagulate soft tissue. The flexible, cooled electrode device, with a suction stabilizer feature, transmits radiofrequency (RF) energy from an Electrosurgical Generator (non-sterile, re-useable) connected through an Instrument Cable (sterile).
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    K Number
    K063012
    Device Name
    NCONTACT COAGULATION SYSTEM KIT, MODEL CSK
    Manufacturer
    NCONTACT SURGICAL, INC.
    Date Cleared
    2006-12-01

    (60 days)

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

    NCONTACT SURGICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The nContact Coagulation System is intended for the coagulation of cardiac tissue using Radiofrequency (RF) energy.
    Device Description
    The nContact Coagulation System consists of a sterile, single-use, disposable coagulation electrode device (2cm & 5cm sizes provided) intended to be used to coagulate cardiac tissue. The flexible, cooled electrode device, with a suction stabilizer feature, transmits radiofrequency (RF) energy from an Electrosurgical Generator (non-sterile, re-useable) connected through an Instrument Cable (sterile).
    Ask a Question

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