Aquarius Low Profile Gastrostomy Feeding Tube
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K132686 FDA 510(k)
- FDA Product Code
- KNT FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 876.5980 FDA 510(k)
- Regulation Number
- 876.5980 FDA 510(k)
- Advisory Committee
- Gastroenterology, Urology FDA 510(k)
- FDA Decision
- SESK Substantially Equivalent — Kit FDA 510(k)
The Aquarius Low Profile Gastrostomy Feeding Tube is a replacement gastrostomy tube designed for long-term enteral access. It is intended to be inserted into a pre-existing, well-established gastrostomy tract to facilitate enteral feeding.
This device is manufactured from silicone material. It has received FDA 510k clearance for use as a gastrostomy feeding tube.
Frequently asked questions
What is the intended use of the Aquarius Low Profile Gastrostomy Feeding Tube?
This device is a replacement gastrostomy tube specifically designed to provide long-term enteral access. It is intended for insertion into a pre-existing, well-established gastrostomy tract to facilitate the delivery of enteral nutrition.
What material is used to manufacture this feeding tube?
The Aquarius Low Profile Gastrostomy Feeding Tube is manufactured from silicone. This material is chosen for its suitability in medical applications requiring long-term contact with the body.
What is the regulatory status of this device?
The Aquarius Low Profile Gastrostomy Feeding Tube has received FDA 510k clearance. This indicates that the device has been reviewed and cleared for use as a gastrostomy feeding tube under the specified regulatory pathway.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Enteral Feeding | QMD Degania, Aquarius Low Profile Gastrostomy Feeding Tube, Aquarius Low Profile Gastrostomy Feeding Tube, Low Profile Gastrostomy Feeding Tube or Gastrotomey Button
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K132686 | Class II | Active |
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Manufacturer
- Manufacturer
- Degania Silicone Ltd
- FDA Applicant
- Degania Silicone , Ltd.
Sources (1)
- FDA 510(k) K132686 24 fields · synced Sep 27, 2026