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510(k) Data Aggregation

    K Number
    K141753
    Device Name
    AQUARIUS NASAL FEEDING TUBE
    Manufacturer
    DEGANIA SILICONE, LTD.
    Date Cleared
    2014-10-16

    (108 days)

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

    DEGANIA SILICONE, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Aquarius™ Nasal Feeding Tubes, /Nasogastric & Nasojejunal / provide nutritional support for patients who require liquid feedings as a substitution for solid food. Intended for enteral administration of nutrients. fluids and/or medications into alimentary tract via natural nasoenteric route. The Aquarius™ Nasogastric Tubes are for the administration of nutrition. fluids and/or medications by the natural naso-enteric route for the patients who are physically unable to ingest enough nutrients through normal mastication and deglutition. Nasogastric feeding tube is designated for patients who require intermittent or continued feeding/and or medication into the stomach. The Aquarius™ Nasojejunal Feeding Tubes are for the administration of . nutrition, fluids and/or medications by the natural naso-enteric route for the patients who are physically unable to ingest enough nutrients through normal mastication and deglutition. Designated for patients who are critically ill and require early enteral feeding/and or medication into the small intestine; may be with a dual tube allowing simultaneous gastric drainage.
    Device Description
    The Aquarius™ Nasal Tube / Nasoqastric Tube (NG-Tube) & Nasojejunal Tube (NJ Tube) / are enteral feeding tubes comprised of flexible tubes and ENFit enteral specific connection access. The tubing part of the devices is constructed with radiopaque polyurethane material and with a hydrophilic coating at the distal end to assist the easy insertion of the tube. The Nasogastric Tube may be with metal stylet and/ or with weighted tip to assist the tube insertion and to maintain the tube in the place. The Nasoieiunal Tube is with stylet and with radiopaque polyurethane antenna tip at the distal end of the tubing to assist to advance the tube into the jejuna. There is an external marking on both NG & NJ-Tubes for measuring of the tube length inserted into the alimentary tract.
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    K Number
    K141631
    Device Name
    AQUARIUS EXTENSION FEEDING SET
    Manufacturer
    DEGANIA SILICONE, LTD.
    Date Cleared
    2014-07-28

    (40 days)

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

    DEGANIA SILICONE, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    AQUARIUS™ Extension Feeding Set is intended for use as an extension set for AQUARIUS™ G-button/ or other gastric feeding device, incorporating safety connectors which help mitigate the risk of accidental connection of an IV system to the enteral system, or the enteral system to IV system.
    Device Description
    The Aquarius™ Extension Feeding Set comprise from the hollow Tube with Connector and Funnel at the ends. The Funnel connects to delivery source of nutrition and the Connector connects to a gastric feeding device. The Aquarius™ Extension Feeding Set is compatible with Aquarius™ Gastrostomy Button (G-Button) and any castric feeding device with Mc-Key™ connection ring. A device is for single patient use only.
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    K Number
    K132686
    Device Name
    AQUARIUS LOW PROFILE GASTROSTOMY FEEDING TUBE
    Manufacturer
    DEGANIA SILICONE, LTD.
    Date Cleared
    2014-05-12

    (257 days)

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

    DEGANIA SILICONE, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    AQUARIUS™ Enternal Extension Set is intended for use as an extension set for AQUARIUSTM G-button' or other gastric feeding device, incorporating safety connectors which help mitigate the risk of accidental connection of an intravenous therapy system to the enteral system, or the enteral system to intravenous therapy system.
    Device Description
    Not Found
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    K Number
    K131020
    Device Name
    TEMPERATURE SENSOR CATHETER
    Manufacturer
    DEGANIA SILICONE, LTD.
    Date Cleared
    2013-05-09

    (27 days)

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

    DEGANIA SILICONE, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    SILICONE FOLEY CATHETER WITH TS, 6FR, intended for urological use only. TSC indicated for drainage of the urinary bladder and simultaneous monitoring of temperature.
    Device Description
    Not Found
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    K Number
    K122030
    Device Name
    LOW PROFILE GASTROSTOMY FEEDING TUBE OR GASTROTOMEY BUTTON
    Manufacturer
    DEGANIA SILICONE, LTD.
    Date Cleared
    2012-09-05

    (56 days)

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

    DEGANIA SILICONE, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Degania Silicone Gastrostomy Button is a replacement gastrostomy tube indicated for long term use in a well established gastrostomy tract for feeding and/or administration of medication. May be used for gastric decompression.
    Device Description
    Not Found
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    K Number
    K103371
    Device Name
    COUDE/ OR TIEMANN
    Manufacturer
    DEGANIA SILICONE, LTD.
    Date Cleared
    2011-03-11

    (114 days)

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

    DEGANIA SILICONE, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Coude Foley catheter / or Tiemann Foley Catheter/ is all silicone Foley catheter 2-way intended for urological use only. Indicated for routine drainage of the urinary bladder. Maximum recommended indwelling time is not more than 30 days. Prescription Use ONLY (Part 21 CFR 801 Subpart D)
    Device Description
    Coude Foley catheter / or Tiemann Foley catheter is all silicone Foley catheter 2-way.
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    K Number
    K070124
    Device Name
    GASTROSTOMY REPLACEMENT TUBE, MODEL 253
    Manufacturer
    DEGANIA SILICONE, LTD.
    Date Cleared
    2007-05-23

    (127 days)

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

    DEGANIA SILICONE, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Gastrostomy Replacement Tube of Degania Silicone Ltd is indicated for use in a well established Gastrostomy tract for feeding and/or administration of medication. May be used for gastric decompression.
    Device Description
    Not Found
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    K Number
    K063442
    Device Name
    ALL SILICONE FOLEY CATHETER, 2-WAY, 3-WAY, WITH TEMPERATURE SENSOR
    Manufacturer
    DEGANIA SILICONE, LTD.
    Date Cleared
    2007-03-26

    (132 days)

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

    DEGANIA SILICONE, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    All Silicone Foley Catheter intended for urological use only. Foley Catheter 2-way: for routine drainage of the urinary bladder. Foley Catheter 3-way: for drainage of the urinary bladder and bladder irrigation. Foley Catheter with Temperature Sensor: for drainage of the urinary bladder and simultaneous monitoring of temperature. Prescription use only.
    Device Description
    Urinary Foley catheter
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    K Number
    K981956
    Device Name
    DEGANIA SILICONE IDENTI LOOPS
    Manufacturer
    DEGANIA SILICONE, LTD.
    Date Cleared
    1998-07-09

    (35 days)

    Product Code
    DXC
    Regulation Number
    870.4450
    Why did this record match?
    Applicant Name (Manufacturer) :

    DEGANIA SILICONE, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Identi Loops are designed and indicated for temporary intraoperative use during various general surgical procedures requiring identification, retraction, or occlusion of tendons, ureters, nerves, arteries, or veins. The Identi Loops is not designed nor indicated for implantation.
    Device Description
    The Identi Loops are designed and indicated for temporary intraoperative use during various general surgical procedures requiring identification, retraction,, or occlusion of tendons, ureters, nerves, arteries or veins. The Identi Loops is not designed nor indicated for implantation. The Identi Loops are manufactured using the same manufacturing processes as our previous 510(k). Both this 510(k) and our previous 510(k) are from silicone rubber. The Degania Silicone Identi Loops have similar technical and performance characteristics to the Substantially Equivalent Identi Loops. Both Identi Loops are available in Mini. Maxi and Super Maxi. The Identi Loops and the Identi Loops to which they are Substantially Equivalent are sterilized by the same process.
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    K Number
    K971482
    Device Name
    DEGANIA SILICONE SIL-K
    Manufacturer
    DEGANIA SILICONE, LTD.
    Date Cleared
    1997-06-24

    (64 days)

    Product Code
    MDA
    Regulation Number
    878.4025
    Why did this record match?
    Applicant Name (Manufacturer) :

    DEGANIA SILICONE, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Sil-K is designed and indicated for treating thick painful, itchy, red and raised hypertrophic or keloid scars.
    Device Description
    Sil-K is a thin soft silicone sheet used to treat thick painful, itchy, red and raised hypertrophic or keloid scars. Sil-K is designed to be used only after the skin has completely healed and is non invasive.
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