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Found 18 results
510(k) Data Aggregation
K Number
K041560Device Name
FLO-ASSISTANT
Manufacturer
NORTHGATE TECHNOLOGIES, INC.
Date Cleared
2004-09-28
(110 days)
Product Code
HIF
Regulation Number
884.1730Why 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
K033614Device 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
884.1730Why 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
K022052Device Name
40LPM ABDOMINAL INSUFFLATOR, CATALOG # 72-00203-0
Manufacturer
NORTHGATE TECHNOLOGIES, INC.
Date Cleared
2003-01-24
(214 days)
Product Code
HIF
Regulation Number
884.1730Why 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
K010053Device 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
884.1730Why 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
K011928Device 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
880.5440Why 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
K001325Device Name
FLO ASSISTANT, MODEL 4-250-00
Manufacturer
NORTHGATE TECHNOLOGIES, INC.
Date Cleared
2000-08-18
(114 days)
Product Code
LJH
Regulation Number
876.5130Why 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
K993778Device Name
HYDROTOWER MANAGEMENT SYSTEM, MODEL 4-750-00
Manufacturer
NORTHGATE TECHNOLOGIES, INC.
Date Cleared
2000-01-06
(59 days)
Product Code
OCX
Regulation Number
876.1500Why 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
K992381Device 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
884.1730Why 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
K990341Device Name
ELECTRO MECHANICAL LITHOTRIPTOR
Manufacturer
NORTHGATE TECHNOLOGIES, INC.
Date Cleared
1999-07-14
(161 days)
Product Code
FFK
Regulation Number
876.4480Why 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
K983326Device Name
OMNIFLATOR 7640 MODEL 7-640-00
Manufacturer
NORTHGATE TECHNOLOGIES, INC.
Date Cleared
1999-02-05
(136 days)
Product Code
HIF
Regulation Number
884.1730Why 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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