Search Filters

Search Results

Found 3 results

510(k) Data Aggregation

    K Number
    K092418
    Device Name
    ENTRACARE GASTROSTOMY FEEDING TUBE
    Manufacturer
    Date Cleared
    2009-10-23

    (78 days)

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

    ENTRACARE, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The EntraCare Gastrostomy Feeding Tube is indicated for use as a replacement gastrostomy tube in an established stoma tract for patients who cannot consume an adequate diet orally. Gastrostomy feeding may be indicated for patients with a functioning stomach who require long term feeding support.
    Device Description
    Not Found
    Ask a Question

    Ask a specific question about this device

    K Number
    K053429
    Device Name
    ADVANCED UROLOGICAL CATHETER
    Manufacturer
    Date Cleared
    2006-02-08

    (61 days)

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

    ENTRACARE, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Advanced Urological Catheter is used to pass fluids to or from the urinary tract.
    Device Description
    Not Found
    Ask a Question

    Ask a specific question about this device

    K Number
    K041034
    Device Name
    SKIN LEVEL GASTROSTOMY TUBE KIT (ECSL)
    Manufacturer
    Date Cleared
    2004-08-31

    (132 days)

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

    ENTRACARE, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The ECSL is a low profile balloon gastrostomy tube indicated for use as a replacement tube in an established stoma tract for pediatric, adult and elderly patients who cannot consume an adequate diet orally. Gastrostomy feeding may be indicated for patients who require long term feeding support. Indicated for patients in whom malnutrition already exists or may result. This may include patients for diseases resulting in an abnormality in swallowing; tumors secondary to head/neck or upper airway diseases or oropharyngeal trauma on the head, neck or overlying swallowing. Some patients who require chronic use of supplemental fluids are also candidates for gastrostomy tube use.
    Device Description
    The EntraCare Skin Level Gastrostomy Tube Kit (ECSL) is used as a replacement tube in an established stoma tract for patients who cannot consume an adequate diet orally. The kit consists of: Gastrostomy Tube, Elbow Connector Extension Set, Bolus Connector Extension set, Stoma Measuring Device, Universal Adapter Subassembly. Items within the kit that are supplied by an outside source: 35 ml Catheter Tipped Syringe, 6 ml Slip Luer Syringe, 4" X 4" Gauze. Item sold separately: Stoma Measuring Device. The Gastrostomy Tube consists of a Feeding Port Valve Subassembly that contains a valve used to open the fluid pathway allowing enteral feeding solutions to enter into the stomach. An inflatable balloon at the distal end secures the tube in the stomach through a stoma. The Gastrostomy Tube size variations include 14-24 French sizes and 0.8-4.5 cm length sizes. There are two slightly different valve designs available, Version 1 and Version 2. The design concept for the Gastrostomy Tube valve Version 1 utilizes a specially designed rubber mechanism that opens the fluid pathway when a bolus or elbow connector is inserted into the device. This specially designed rubber valve will seal around the connectors preventing leakage and allow unrestricted access into the fluid pathway. When the connections are removed, the valve will reseal immediately preventing leakage of fluids. The design concept for the Gastrostomy Tube valve Version 2 utilizes a specially designed silicone mechanism that opens the fluid pathway when a bolus or elbow connector is inserted into the device. This specially designed valve will seal around the connectors preventing leakage and allow unrestricted access into the fluid pathway. The Gastrostomy Tube also consists of an Inflation Valve Subassembly that contains a valve and spring mechanism. When the syringe is inserted into the Inflation Valve Subassembly, the tip pushes against the valve, which compresses the spring and opens the fluid path to inflate the balloon. The Skin Level Gastrostomy Tube Kit contains all delivery items (accessories) necessary for enteral feeding applications. The accessories provided in the kit are two Extension Sets; one that allows continuous feeding from a pump, and the other that allows feeding from a catheter tip syringe. Two syringes are supplied (which have either been previously cleared for marketing by the FDA or are pre amendment devices); the 6 ml syringe is used to inflate the balloon of the gastrostomy tube and the 35 ml catheter tip syringe is used for bolus feeding. Sterile gauze is provided for absorbency. A universal luer adapter is included for mating connections that require a female luer.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1