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510(k) Data Aggregation

    K Number
    K201741
    Device Name
    Gabriel 3 Way EnFit Valve
    Date Cleared
    2020-11-05

    (133 days)

    Product Code
    Regulation Number
    876.5980
    Why did this record match?
    Applicant Name (Manufacturer) :

    Syncro Medical Innovations, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Gabriel 3-way EnFit valve is a three-way closed system valve with three ports for control of fluid flow (nutrition, medication and water) between devices with EnFit connectors and catheter tip syringe. It can be used in pediatric, adult and elderly patients, for up to 7 days.
    Device Description
    The Gabriel 3-way EnFit Valve is a three-way stopcock valve that is intended to control fluid flow between enteral devices (feeding tubes and feeding lines) with EnFit compatible connectors in a closed system fashion that reduces the need for frequent connection of the EnFit ports. It has one male EnFit port, one female EnFit port and one catheter tip port. The catheter tip port can be used for flushing and administration of medication using a catheter tip syringe. The male EnFit port is provided with a tethered cap and the catheter tip port is provided with a tethered cap. The ability to use a catheter tip syringe for flushing and administration of medicine in health care facilities that do not carry EnFit syringes, may facilitate adoption of feeding tubes and feeding lines with EnFit connectors.
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    K Number
    K191784
    Device Name
    Gabriel Feeding Tube with Balloon, and EnFit Connector
    Date Cleared
    2019-11-15

    (135 days)

    Product Code
    Regulation Number
    876.5980
    Why did this record match?
    Applicant Name (Manufacturer) :

    Syncro Medical Innovations, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Gabriel® Feeding Tube with Balloon functions as a conduit to facilitate enteral feeding, and may be used in adult or elderly patients who cannot consume an adequate diet orally. Small bowel feeding may be indicated for patients with functioning gut who require short to moderate term feeding support, such as post-trauma patients, burn patients, general trauma patients, high-risk patients prone to tube misplacement complications, and patients in whom malnutrition exist, or may result, secondary to an underlying disease or condition.
    Device Description
    The Gabriel Feeding Tube with Balloon serves as conduit through which enteral feeding solutions are directly infused into patients small bowel. The tube has two distal end openings, one distal end balloon, one proximal end pilot balloon that indicates the status of the inflation of the distal end balloon and a proximal end EnFit connector that replaced our Y shaped catheter tip connector of the predicate device. The tube shaft is lined by a monofilament spiral wire to prevent occlusion from kinking. A braided 7 strands stainless steel stiffening central stylet prevents coiling in the mouth during insertion and provides column strength to facilitate placement into the stomach.The tube patient contacting material is made from DEHP-free PVC. Size 12 Fr tube is 130 cm long.
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    K Number
    K160787
    Device Name
    Gabriel Feeding Tube with Balloon, Magnetically Guided Feeding Tube w/Balloon, Gabriel Feeding Tube with Balloon, Preassembled with Stylet
    Date Cleared
    2016-08-09

    (140 days)

    Product Code
    Regulation Number
    876.5980
    Why did this record match?
    Applicant Name (Manufacturer) :

    SYNCRO MEDICAL INNOVATIONS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Gabriel Feeding Tube with balloon functions as a conduit to facilitate enteral feeding, and may be used in adult or elderly patients who cannot consume an adequate diet orally. Small bowel feeding may be indicated for patients with functioning gut who require short to moderate term feeding support, such as post-trauma patients, general trauma patients, high-risk patients prone to tube misplacement complications, and patients in whom malnutrition exist, or may result, secondary to an underlying disease or condition.
    Device Description
    The Gabriel Feeding Tube with Balloon serves as a conduit through which enteral feeding solutions are directly infused into the patients small bowel. During placement of the tube, a lubricant and or numbing gel is applied to the nostril. For the version of the tube with stylet with magnetic tips, an external magnet is used to assist the physician in placing the tube into the small bowel. Like the predicate device, the modified device has a stylet with a reed switch positioned near its distal tip. The reed switch is connected by wires to an external LED/battery pack that lights in response to the presence of the external steering magnet. The reed switch is encased in a lead-free glass tube and metal shield and is attached to the distal end of the stylet. The wires used to connect the distal reed switch to the LED are polyurethane insulated copper and are wrapped around the core of the stylet and contained inside the outer PTFE layer, thus keeping it out of the fluid path. The distal tip of the stylet contains magnets which are attracted to the steering magnet. The inflated feeding tube balloon allows peristalsis to advance the feeding tube distally. For the version of the tube with the non-magnetic stylet, the tube is manually inserted by the physician. The stylet, is non patient contacting, made out of seven braided filaments 305 stainless steel wire and is 3 cm shorter than the feeding tube. The stylet is removed and tube taped at the nose and placement verified by pH paper and abdominal x-ray. Like the predicate device, the modified Gabriel Feeding Tube with Balloon has a stylet. The inflated feeding tube balloon allows peristalsis to advance the feeding tube distally. The external tube is extruded over reinforcing monofilament stainless steel wire that prevents occlusion by kinking. The outer patient contacting layer is made from DEHP-free PVC.
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    K Number
    K110005
    Device Name
    SYNCRO - BLUE TUBE, THE MAGNETICALLY GUIDED ENTERAL FEEDING TUBE- 8FR TUBE
    Date Cleared
    2011-08-04

    (213 days)

    Product Code
    Regulation Number
    876.5980
    Why did this record match?
    Applicant Name (Manufacturer) :

    SYNCRO MEDICAL INNOVATIONS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Syncro-Blue Tube™ functions as a conduit to facilitate enteral feeding, and may be used in the pediatric, adult or elderly patient who cannot consume an adequate diet orally. Small bowel feeding may be indicated for patients with functioning gut who require short- to moderate-term feeding support, such as posttrauma patients, post-surgical patients, burn patients, general trauma patients, high-risk patients prone to tube misplacement complications, and patients in whom malnutrition exists, or may result, secondary to an underlying disease or condition.
    Device Description
    The Syncro-Blue Tube serves as a conduit through which enteral feeding solutions are directly infused into the patient's small bowel. The modified device will be marketed in one length (23.6" [60cm]) and one French size (8 Fr). During placement of the tube, an external magnet is used to assist the physician in placing the tube into the small bowel. The Syncro-Blue Tube has a stylet with a reed switch positioned near its distal tip. The reed switch is connected by wires to an external LED/battery pack that lights in response to the presence of the external steering magnet. The reed switch is located at the distal end of the stylet. The distal tip of the stylet contain magnets which are attracted to the steering magnet. When the tube is positioned, the stylet is removed from the device, making the Syncro-Blue Tube MRI Safe.
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    K Number
    K072787
    Device Name
    GABRIEL BLUE TUBE MAGNETICALLY GUIDED ENTERAL FEEDING TUBE, MODEL GFT-111
    Date Cleared
    2007-10-31

    (30 days)

    Product Code
    Regulation Number
    876.5980
    Why did this record match?
    Applicant Name (Manufacturer) :

    SYNCRO MEDICAL INNOVATIONS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Gabriel Blue Tube Magnetically Guided Enteral Feeding Tube is intended for direct placement into the small bowel. The tube functions as a conduit to facilitate enteral feeding, and may be used in pediatric, adult or elderly patients who cannot consume an adequate diet orally. Small bowel feeding may be indicated for patients with a functioning gut who require short- to moderate-term feeding support, such as post-trauma patients, post-surgical patients, burn patients, general trauma patients, high-risk patients prone to tube misplacement complications, and patients in whom mainutrition exists, or may result, secondary to an underlying disease or condition.
    Device Description
    The Gabriel Blue Tube serves as a conduit through which enteral feeding solutions are directly infused into the patient's small bowel. The device will be marketed in one length (50" [127cm]) and one French size (11 Fr). The feeding tube contains a stylet which has magnets attached to its tip. An external magnet is used to capture the tip and guide the device to the duodenum. A reed switch and light indicate when the magnet has been captured and can be guided to its final location.
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    K Number
    K021991
    Device Name
    MAGNAFLOW MAGNETICALLY GUIDED ENTERAL FEEDING TUBE
    Date Cleared
    2002-07-18

    (30 days)

    Product Code
    Regulation Number
    876.5980
    Why did this record match?
    Applicant Name (Manufacturer) :

    SYNCRO MEDICAL INNOVATIONS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The MagnaFlow® Magnetically Guided Enteral Feeding Tube functions as a conduit to facilitate enteral feeding, and may be used in pediatric, adult or elderly patients who cannot consume an adequate diet orally. Small bowel feeding may be indicated for patients with a functioning gut who require short- to moderate-term feeding support, such as post-trauma patients, post-surgical patients, burn patients, general trauma patients, high-risk patients prone to tube misplacement complications, and patients in whom malnutrition exists, or may result, secondary to an underlying disease or condition.
    Device Description
    The MagnaFlow® Magnetically Guided Enteral Feeding Tube system is intended for direct placement in the small bowel. The catheter functions as a conduit for enteral feeding for patients who cannot consume an adequate diet orally. The catheter has a magnet embedded in the distal tip, which through the use of an external magnet aids in catheter placement. When the external magnet is in close proximity to the catheter tip, a reed switch (located proximal to tube tip magnet) closes, causing an LED light (in manifold) to illuminate. That light indicates when the external magnet has captured the tube distal portion. The external magnet can steer the catheter through the stomach pyloric sphincter into the duodenum.
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