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510(k) Data Aggregation

    K Number
    K041560
    Device Name
    FLO-ASSISTANT
    Manufacturer
    NORTHGATE TECHNOLOGIES, INC.
    Date Cleared
    2004-09-28

    (110 days)

    Product Code
    HIF
    Regulation Number
    884.1730
    Why did this record match?
    Applicant Name (Manufacturer) :

    NORTHGATE TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Nortech Flo-Assistant™ Product is indicated to provide a squeezing mechanism to a tubing set, providing increased capacity fluid irrigation for arthroscopic procedures.
    Device Description
    The Flo-Assistant™ is designed to be used with the Nortech® 7-510-33 Flo-Assistant™ tubing set for increased fluid capacity. The device is comprised of a main unit, cable and foot pedal assembly.
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    K Number
    K033614
    Device Name
    MISTIC HUMIDIFICATION SYSTEM 850-00/01/02, 2215
    Manufacturer
    NORTHGATE TECHNOLOGIES, INC.
    Date Cleared
    2004-07-29

    (255 days)

    Product Code
    HIF
    Regulation Number
    884.1730
    Why did this record match?
    Applicant Name (Manufacturer) :

    NORTHGATE TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The NORTECH IntraMyst Humidification System is indicated for use as a means of supplying humidity within the intra-abdominal cavity during diagnostic and/or operative laparoscopic procedures.
    Device Description
    Nortech's IntraMyst Humidification System incorporates front panel controls that are similar to Northgate's current Insufflators. The system is designed to provide continuous or on demand humidification to the laparoscopic environment. This may reduce the incidence of postoperative pain, diminish the likelihood of adhesion formation and reduce laparoscope lens fogging. The controller will contain the appropriate pneumatics for supplying and controlling the gas to the catheter at 100 PSI and 5 LPM. In addition, the controller will have displays for indicating abdominal pressure, overpressure, gas supply low, mist active, active pressure sense and amount of fluid dispensed.
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    K Number
    K022052
    Device Name
    40LPM ABDOMINAL INSUFFLATOR, CATALOG # 72-00203-0
    Manufacturer
    NORTHGATE TECHNOLOGIES, INC.
    Date Cleared
    2003-01-24

    (214 days)

    Product Code
    HIF
    Regulation Number
    884.1730
    Why did this record match?
    Applicant Name (Manufacturer) :

    NORTHGATE TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The NORTECH 40LPM ABDOMINAL INSUFFLATOR®, 72-00203-0 SHALL BE USED FOR GAS DISTENTION OF THE ABDOMEN FOR DIAGNOSTIC AND/OR OPERATIVE LAPAROSCOPY.
    Device Description
    The Abdominal CO, Gas Insufflator (catalog # 72-00203-0) incorporates front panel controls similar to our current Omniflator® model #7640, although it utilizes membrane switches. The Abdominal Insufflator has an adjustable gas flow rate from 0-40 LPM. The unit shall have direct patient pressure monitoring which can be used by attaching the direct patient monitoring tubing set to the Omniflator® patient monitoring connector and subsequently into a cannula or trocar after initial insufflation has been achieved. The user has an option to utilize CO2 from a central supply or E-Cylinder tank.
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    K Number
    K010053
    Device Name
    HUMI-FLOW, MODEL 6-850-00/ 01/02
    Manufacturer
    NORTHGATE TECHNOLOGIES, INC.
    Date Cleared
    2001-10-23

    (288 days)

    Product Code
    HIF
    Regulation Number
    884.1730
    Why did this record match?
    Applicant Name (Manufacturer) :

    NORTHGATE TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K011928
    Device Name
    HYDROTOWER ARTHROSCOPIC ADMINISTRATION TUBING SET, MODEL 7-460-05
    Manufacturer
    NORTHGATE TECHNOLOGIES, INC.
    Date Cleared
    2001-08-10

    (51 days)

    Product Code
    FPA, GCJ
    Regulation Number
    880.5440
    Why did this record match?
    Applicant Name (Manufacturer) :

    NORTHGATE TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    THE HYDROTOWER® ARTHROSCOPIC ADMINISTRATION TUBING SET IS USED TO MOVE FLUID FROM THE TOWER BAG TO THE PATIENT.
    Device Description
    The Hydrotower® Arthroscopic Administration Tubing Set is designed to be used with the Nortech® Hydrotower® System. The device is comprised of pvc tubing, check valve, a pressure relief valve, and numerous polymer fittings.
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    K Number
    K001325
    Device Name
    FLO ASSISTANT, MODEL 4-250-00
    Manufacturer
    NORTHGATE TECHNOLOGIES, INC.
    Date Cleared
    2000-08-18

    (114 days)

    Product Code
    LJH
    Regulation Number
    876.5130
    Why did this record match?
    Applicant Name (Manufacturer) :

    NORTHGATE TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K993778
    Device Name
    HYDROTOWER MANAGEMENT SYSTEM, MODEL 4-750-00
    Manufacturer
    NORTHGATE TECHNOLOGIES, INC.
    Date Cleared
    2000-01-06

    (59 days)

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

    NORTHGATE TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    THE NORTECH HYDROTOWER FLUID MANAGEMENT SYSTEMS SHALL BE USED FOR SUPPLYING FLUID FOR GENERAL ENDOSCOPIC PROCEDURES.
    Device Description
    The Hydrotower ® Fluid Management System incorporates a peristaltic pump, motor, controller, power supply, and associated tubing and a sensor. The product allows continuous flow to an Endoscopic instrument by the constant refilling of a fluid "reservoir" bag. The control of flow rates and source pressures remains in the physician's control by the conventional method of raising or lowering the "reservoir" bag.
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    K Number
    K992381
    Device Name
    CO2 GAS WARMER II, MODEL 6-800-00
    Manufacturer
    NORTHGATE TECHNOLOGIES, INC.
    Date Cleared
    1999-09-17

    (63 days)

    Product Code
    HIF
    Regulation Number
    884.1730
    Why did this record match?
    Applicant Name (Manufacturer) :

    NORTHGATE TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    THE NORTECH GAS WARMER II IS INDICATED FOR WARMING GAS (95-1059F/35-40.5°C) USED FOR THE DISTENTION OF THE ABDOMEN FOR DIAGNOSTIC AND/OR OPERATIVE LAPAROSCOPY.
    Device Description
    The CO, Gas Warmer II Unit is designed to be used in conjunction with an insufflator to provide continuous non-adjustable heating of gas to a laparoscopic instrument. The CO2 Gas Warmer II Unit is comprised of a control unit and reusable heat exchanger and power cords.
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    K Number
    K990341
    Device Name
    ELECTRO MECHANICAL LITHOTRIPTOR
    Manufacturer
    NORTHGATE TECHNOLOGIES, INC.
    Date Cleared
    1999-07-14

    (161 days)

    Product Code
    FFK
    Regulation Number
    876.4480
    Why did this record match?
    Applicant Name (Manufacturer) :

    NORTHGATE TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Nortech® Electro-Mechanical Lithotriptor (EML) was designed to be used with Nortechs'® Intracorporeal Electro-Mechanical Lithotriptor probes for the fragmentation of urinary calculi.
    Device Description
    The Intracorporeal Electro-Mechanical Lithotriptor (EML) generator incorporates front panel controls that include a lighted main "Power Switch." An "Energy Switch" and "Rate Switch".
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    K Number
    K983326
    Device Name
    OMNIFLATOR 7640 MODEL 7-640-00
    Manufacturer
    NORTHGATE TECHNOLOGIES, INC.
    Date Cleared
    1999-02-05

    (136 days)

    Product Code
    HIF
    Regulation Number
    884.1730
    Why did this record match?
    Applicant Name (Manufacturer) :

    NORTHGATE TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    THE NORTECH OMNIFLATOR® 7640 SHALL BE USED FOR GAS DISTENTION OF THE ABDOMEN FOR DIAGNOSTIC AND / OR OPERATIVE LAPAROSCOPY.
    Device Description
    The Omniflator® Model 7640 CO, Gas Insufflator incorporates front panel controls similar to our current Omniflator® Model #6630/6600. The 7640 has an adjustable gas flow rate from 0-40 LPM. The unit shall have direct patient pressure monitoring which can be used by attaching the direct patient monitoring tubing set to the Omniflator's® patient monitoring connector and subsequently into a cannula or trocar after initial insufflation has been achieved. The user has an option to utilize CO, from a central supply or E-Cylinder tank.
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