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510(k) Data Aggregation

    K Number
    K140263
    Device Name
    INSUFLOW SYNERGY PORT, INSUFLOW SYNERGY XL PORT
    Manufacturer
    LEXION MEDICAL, LLC.
    Date Cleared
    2014-03-05

    (30 days)

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

    LEXION MEDICAL, LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Insuflow Synergy™ Port (5 mm) and Insylow® Synergy™ XL Port (8 mm, 10mm and 12mm) have applications in thoracic, abdominal and gynecologic minimally invasive endoscopic surgical procedures to establish a path of entry for endoscopic instruments and to heat, humidify, filter and introduce a CO2 gas stream for insufflation of the surgical cavity.
    Device Description
    The Insuflow® Synergy™ and Insuflow® Synergy™ XL Port devices are gas conditioning devices that attach to the outlet port of an insufflator or other regulated CO2 source and are design and humidify the CO2 gas stream prior to insufflation via an integral path of entry device during minimally invasive surgery. The Insuflow® Synergy™ XL Port consist of a sterile, disposable single use device with a filter, heater/humidifier, tubing set, and a path of entry access port device. A reusable control module houses the control and safety circuits for the system.
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    K Number
    K132203
    Device Name
    PNEUVIEW XE VERYCLEAR GAS EVACUATION CANNULA
    Manufacturer
    LEXION MEDICAL, LLC.
    Date Cleared
    2013-09-20

    (66 days)

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

    LEXION MEDICAL, LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    PneuVIEW® XE VeryClear™ Gas Evacuation Cannula has applications in thoracic, abdominal and gynecologic minimally invasive endoscopic surgical procedures to establish a path of entry for endoscopic instruments and to evacuate smoke and plume generated during minimally invasive surgery from the surgical cavity to aid visualization.
    Device Description
    The PneuVIEW® XE VeryClear™ Gas Evacuation Cannula (Dual and Single Lumen Port) is an integral path of entry access port device with smoke evacuation mechanism intended for use in the surgical cavity during minimally invasive surgery. The PneuVIEW® XE VeryClear™ is a disposable single use device consisting of a path of entry access port device with filter and tubing with a multi-position stopcock valve. The PneuVIEW® XE VeryClear™ can be connected to a vacuum source for smoke evacuation. The integral path of entry access port device is designed and constructed similarly to the ' predicate Insuflow Synergy™ Port access device with a sealed instrument access lumen. Just as the Insuflow® Synergy™ Port, the PneuVIEW® XE VeryClear™ has a dual-lumen or single-lumen path of entry access device 5 mm configuration for surgical instrument manipulation and smoke evacuation.
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    K Number
    K132204
    Device Name
    INSUFLOW SYNERGY XL PORT
    Manufacturer
    LEXION MEDICAL, LLC.
    Date Cleared
    2013-08-22

    (37 days)

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

    LEXION MEDICAL, LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Insuflow® Synergy™ XL Port (10mm and 12mm) and Insuflow® Synergy™ XLR Port (10mm and 12mm with endoscopic cannula seal) have applications in thoracic, abdominal and gynecologic minimally invasive endoscopic surgical procedures to establish a path of entry for endoscopic instruments and to heat, humidify, filter and introduce a CO2 gas stream for insufflation of the surgical cavity.
    Device Description
    The Insuflow® Synergy™ XL and XLR Port are a gas conditioning device that attaches to the outlet port of an insufflator or other regulated CO2 source and is designed to warm and humidify the CO2 gas stream prior to insufflation via an integral path of entry device during minimally invasive surgery. The Insuflow Synergy™ XL and XLR Port consist of a sterile, disposable single use device with a filter, heater/humidifier, tubing set, and a path of entry access port device. A reusable control module houses the control and safety circuits for the system. The integral path of entry access device in the Insuflow Synergy™ XL and XLR Port is designed and constructed similarly to the Insuflow® Synergy™ Port but comes in larger sizes just as the predicate EndoPath trocar device. The Insuflow® Synergy™ XL Port and the Insuflow® Synergy™ XLR Port have access devices in 10 mm and 12 mm configurations with a single-lumen working channel configuration for conditioned gas delivery. The access device has a working channel with duckbill and tool seals for instrument entry into the surgical cavity and delivers conditioned insufflation gas through the working channel. The Insuflow® Synergy™ XLR Port has an endoscope compatible configuration that has an additional seal at the bottom of the main cannula, which serves as a means to seal off around the endoscope, forcing all gas flow out of the peripheral gas exhaust ports. This minor change is intended to reduce fogging and improve visualization. The obturator for the Insuflow Synergy™ XL and XLR Port has a transparent optical window at the distal end, which when used with an endoscope, provides visibility of individual tissue layers during insertion.
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    K Number
    K120640
    Device Name
    INSUFLOW SYNERGY PORT
    Manufacturer
    LEXION MEDICAL, LLC.
    Date Cleared
    2012-07-18

    (138 days)

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

    LEXION MEDICAL, LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Insuflow® Synergy™ Port has applications in thoracic, abdominal and gynecologic minimally invasive endoscopic surgical procedures to establish a path of entry for endoscopic instruments and to heat, humidify, filter and introduce a CO2 gas stream for insufflation of the surgical cavity.
    Device Description
    The Insuflow Synergy™ Port (Dual and Single Lumen) is a gas conditioning device that attaches to the outlet port of an insufflator or other regulated CO2 source and is designed to warm and humidify the CO2 gas stream prior to insufflation via an integral path of entry device during minimally invasive surgery. The Insuflow Synergy™ Port consists of a disposable single use device with a filter, heater/humidifier, tubing set, and a path of entry access port device. A reusable control module houses the control and safety circuits for the svstem. Regulated CO2 gas flows into the Insuflow® Synergy™ Port, through the in-line filter, continues along the tubing to enter the path of entry access device that contains the heating element and humidification media, and through the path of entry access device lumen for delivery into the patient's surgical cavity. The integral path of entry access device is designed and constructed similarly to the predicate trocar device with a sealed instrument access lumen. The Insuflow® Synergy™ Port (Dual and Single Lumen) has a dual-lumen or single-lumen path of entry access device configuration for conditioned gas delivery. Both configurations have a working channel with duckbill and tool seals for instrument entry into the surgical cavity. The single lumen device delivers conditioned insufflation gas through the working channel while the dual lumen configuration has a second outer lumen channel for conditioned gas delivery.
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    K Number
    K112357
    Device Name
    VESSEL GUARDIAN
    Manufacturer
    LEXION MEDICAL, LLC.
    Date Cleared
    2011-11-10

    (86 days)

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

    LEXION MEDICAL, LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Vessel Vapor™ is a gas conditioner accessory device intended to heat, humidify and filter an insufflating CO2 gas stream being used in minimally invasive cardiovascular, thoracoscopic, and vessel harvesting surgical procedures.
    Device Description
    The Vessel Vapor™ device is a single use device that attaches to the outlet port of an insufflator or other regulated CO2 source and is designed to warm and humidify the CO2 gas stream prior to insufflation into the surgical cavity. The Vessel Vapor™ device consists of a disposable tubing set with a filter and heater/humidifier cassette and a control module that houses the control and safety circuits for the system. Regulated CO2 gas flows into the Vessel Vapor™ device, through the in-line filter, continues along the tube to enter the Vessel Vapor™ device cassette that contains the heating element and humidification media, through a tube that connects via a Luer lock connector to a gas entrance port or an insufflation needle/trocar and finally flows into the patient's surgical cavity.
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    K Number
    K102136
    Device Name
    VESSEL GUARDIAN
    Manufacturer
    LEXION MEDICAL, LLC.
    Date Cleared
    2010-09-27

    (60 days)

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

    LEXION MEDICAL, LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Vessel Guardian®is a gas conditioner accessory device for use in endoscopic vessel harvesting surgical procedures, intended to heat, humidify and filter a CO2 gas stream for insufflation of the surgical cavity.
    Device Description
    The Vessel Guardian® device is a single use device that attaches to the outlet port of an insufflator or other regulated CO2 source and is designed to warm and humidify the CO2 gas stream prior to insufflation into the surgical cavity. The Vessel Guardian® device consists of a disposable filter heater/humidifier tubing set and a control module that houses the control and safety circuits for the system. Regulated CO2 gas flows into the Vessel Guardian® device, through the in-line filter, continues along the tube to enter the Vessel Guardian® device cassette that contains the heating element and humidification media, through a tube that connects via a Luer lock connector to a gas entrance port or an insufflation needle/trocar and finally flows into the patient's surgical cavity.
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    K Number
    K101320
    Device Name
    VASOVAPOR
    Manufacturer
    LEXION MEDICAL, LLC.
    Date Cleared
    2010-06-24

    (44 days)

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

    LEXION MEDICAL, LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    VasoVapor™ is a gas conditioner accessory device for use in endoscopic vessel harvesting surgical procedures, intended to heat, humidify and filter a CO2 gas stream for insufflation of the surgical cavity.
    Device Description
    The VasoVapor™ device is a single use device that attaches to the outlet port of an insufflator or other regulated CO2 source and is designed to warm and humidify the CO2 gas stream prior to insufflation into the surgical cavity. The Vaso Vapor™ device consists of a disposable filter heater/humidifier tubing set and a control module that houses the control and safety circuits for the system. Regulated CO2 gas flows into the VasoVapor™ device, through the in-line filter, continues along the tube to enter the VasoVapor™ device cassette that contains the heating element and humidification media, through a tube that connects via a Luer lock connector to a gas entrance port or an insufflation needle/trocar and finally flows into the patient's surgical cavity.
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    K Number
    K091366
    Device Name
    INSUFLOW DEWHEART
    Manufacturer
    LEXION MEDICAL, LLC.
    Date Cleared
    2009-09-03

    (118 days)

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

    LEXION MEDICAL, LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Insuflow® DewHeart™ is a Blower/Mister Gas conditioner device for use in cardiovascular surgical procedures intended to heat, humidify and filter a CO2 gas stream for introduction into the surgical cavity to improve visibility and reduce the risk of air embolism.
    Device Description
    The Insuflow DewHeart™ device is a single use blower/mister device that attaches to the outlet port of the Insuflow controller with regulated CO2 source and is designed to warm and humidify the CO2 gas stream prior to introduction into the cardiovascular cavity. The Insuflow DewHeart™ device consists of a disposable filter heater/humidifier tubing set and a control module that houses the control and safety circuits for the system. Regulated CO2 gas flows into the Insuflow® DewHeart™ device, through the in-line filter, continues along the tube to enter the Insuflow® DewHeart™ device cassette that contains the heating element and humidification media, through a nozzle/wand for directional. localization of a CO2 gas stream entry into the patient's surgical cavity
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    K Number
    K090456
    Device Name
    INSUFLOW
    Manufacturer
    LEXION MEDICAL, LLC.
    Date Cleared
    2009-08-26

    (184 days)

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

    LEXION MEDICAL, LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Insuflow is a gas conditioner accessory device for use in minimally invasive surgery, including thoracoscopic, laparoscopic and endoscopic vein harvesting surgical procedures, intended to heat, humidify and filter a CO2 gas stream for insufflation of the surgical cavity.
    Device Description
    The Insuflow device is a single use device that attaches to the outlet port of an insufflator or other regulated CO2 source and is designed to warm and humidify the CO2 gas stream prior to insufflation into the cardiothoracic, vascular or abdominal surgical cavity. The Insuflow device consists of a disposable filter heater/humidifier tubing set and a control module that houses the control and safety circuits for the system. Regulated CO2 gas flows into the Insuflow® device, through the in-line filter, continues along the tube to enter the Insuflow® device cassette that contains the heating element and humidification media, through a tube that connects via a Luer lock connector to anno a insufflation needle/trocar and finally flows into the patient's surgical cayity over and finally
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    K Number
    K090879
    Device Name
    INSUFLOW CO2IONSHIELD
    Manufacturer
    LEXION MEDICAL, LLC.
    Date Cleared
    2009-07-23

    (114 days)

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

    LEXION MEDICAL, LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Insuflow® CO2lonShield™ is a gas conditioner accessory device for use during colonoscopy procedures, including CT Colonography (CTC or Virtual Colonoscopy) and conventional Colonoscopy procedures, and intraoperative endoscopy procedures, intended to heat, humidify and filter a CO2 gas stream for administration as a distention media.
    Device Description
    The Insuflow® CO2lonShield™ device is a single use device that attaches to the outlet port of a regulated CO2 source and is designed to warm and humidify the CO2 gas stream prior to gas delivery during colonoscopy and intraoperative endoscopy procedures. The Insuflow® CO2lonShield™ device consists of a disposable filter heater/humidifier tubing set and a control module that houses the control and safety circuits for the system. Regulated CO2 gas flows into the Insuflow® CO2lonShield™ device, through the inline filter, continues along the tube to enter the Insuflow® CO2lonShield™ device cassette that contains the heating element and humidification media, through a tube that connects to an endoscope/colonoscope or rectal probe for gas delivery into the patient's gastroenterological cavity.
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