Search Results
Found 3 results
510(k) Data Aggregation
K Number
K233591Device Name
Stylus
Manufacturer
Date Cleared
2024-05-31
(205 days)
Product Code
Regulation Number
876.5980Why 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.
Ask a Question
Ask a specific question about this device
K Number
K152246Device Name
Aquarius Stoma Measuring Device
Manufacturer
Date Cleared
2016-06-21
(316 days)
Regulation Number
876.5980Why 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.
Ask a Question
Ask a specific question about this device
K Number
K143378Device Name
AQUARIUS Gastrostomy Replacement Tube
Manufacturer
Date Cleared
2014-12-29
(34 days)
Regulation Number
876.5980Why 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.
Ask a Question
Ask a specific question about this device
Page 1 of 1