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510(k) Data Aggregation

    K Number
    K233591
    Device Name
    Stylus
    Date Cleared
    2024-05-31

    (205 days)

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

    Degania Silicone Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Stylus is intended to assist in the placement of Low-Profile Gastrostomy Feeding Tube or Gastrostomy Button by providing temporary feeding tube stability during insertion through patient stoma tract.
    Device Description
    The Stylus (may also be referred as Stylet, Introducer, Obturator or Stiffener) is an Introducer for the Low-Profile Gastrostomy Feeding Tube or Gastrostomy Button (LPGFT/B - K122030) originally cleared in July 2012 which was developed at Degania Silicone Ltd. The Stylus is made of Polycarbonate (Macrolon®) and has various ranges of lengths, colors and weights. The Stylus is inserted all the way into the Feeding Port of the LPGFT/B port of the cleared gastrostomy device. The use of the Stylus is optional, it provides stiffness to the LPGFT/B shaft to guide the LPGFT/B through the stoma. The Stylus should not exceed the buttons distal tip. The Stylus is being sterilized by Ethylene Oxide (EtO) along with a compatible Low Profile Gastrostomy Feeding Tube/ Gastrostomy Button kit, rather than a standalone device.
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    K Number
    K152246
    Device Name
    Aquarius Stoma Measuring Device
    Date Cleared
    2016-06-21

    (316 days)

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

    DEGANIA SILICONE LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Aquarius™ Stoma Measuring Device is designed to determine the depth (length) of a well-established gastrostomy stoma tract in order to assist in proper length selection of the Aquarius™ Gastrostomy Button (G-Button). Intended for transient use (less than 60 minutes).
    Device Description
    The Aquarius™ Stoma Measuring Device comprises a 12 Fr with graduated scale, a funnel with an inflation valve and a tubular shaft retaining balloon. The Aquarius™ Stoma Measuring Device is made of 100% silicone, EtO sterilized and for single use. Intended to be use in hospital environment.
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    K Number
    K143378
    Device Name
    AQUARIUS Gastrostomy Replacement Tube
    Date Cleared
    2014-12-29

    (34 days)

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

    DEGANIA SILICONE LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    AQUARIUS™ Gastrostomy Replacement Tube is intended for use in a well-established gastrostomy tract for feeding and/or administration of medications. May be used for gastric decompression.
    Device Description
    Aquariusi Gastrostomy Replacement Tube is a silicone feeding tube comprised of a double lumen tube with external proximal specific ENFit safety access port/s, external retention disk, balloon, and distal open flow-through tip. The tube is with external graduations (cm) and radiopaque marker at the distal end. The tube size and balloon capacity are clearly indicated on the shaft and pouch of each device. The tube is made without use of natural latex, BPA, or phthalates plasticizers.
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