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Low Profile Gastrostomy Feeding Tube Or Gastrotomey Button

FDA 510(k)

Class II (US FDA 510(k))

510(k) K122030

by Degania Silicone Ltd

Identifiers

510(k) Number
K122030 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
SESE Substantially Equivalent FDA 510(k)

This device is a low-profile gastrostomy button (per FDA nomenclature), a type of enteral feeding tube designed for long-term gastric access. It serves as a conduit for the administration of nutritional formulas, medications, or gastric decompression in patients with established gastrostomy tracts. Constructed from silicone, it is intended for replacement use in pre-existing stomas, providing a secure and stable interface for sustained enteral support. The design prioritises minimal profile and patient comfort while maintaining functional reliability for clinical or homecare settings.

The Low Profile Gastrostomy Feeding Tube or Gastrotomy Button is supplied sterile for single-use and is intended for insertion into a pre-established gastrostomy tract. It is classified under product code KNT and has received FDA 510(k) clearance (K122030) as substantially equivalent to predicate devices. The device is not MRI-safe unless explicitly stated in accompanying documentation, and storage conditions must adhere to manufacturer guidelines to preserve sterility and integrity. Availability is through healthcare providers or distributors authorised by Degania Silicone Ltd., Israel.

Frequently asked questions

What is the Degania Low-Profile Gastrostomy Button used for?

This device is a low-profile gastrostomy button intended for long-term gastric access in patients with established gastrostomy tracts. It serves as a conduit for administering nutritional formulas, medications, or performing gastric decompression. The design ensures a secure and stable interface for sustained enteral support in both clinical and homecare settings.

How is the Degania Low-Profile Gastrostomy Button supplied and for what purpose?

The device is supplied sterile and intended for single-use replacement in pre-existing gastrostomy stomas. It is not meant for initial stoma creation but rather for maintaining established access when a patient requires ongoing enteral feeding or decompression.

Is the Degania Low-Profile Gastrostomy Button reusable or single-use?

This device is explicitly designed for single-use only. Its sterile packaging ensures safety for one-time insertion into a pre-existing stoma, after which it should be discarded to prevent contamination and maintain patient safety.

What storage conditions are required to maintain the device’s integrity?

To preserve sterility and functionality, the device must be stored according to the manufacturer’s guidelines provided in the accompanying documentation. This typically includes keeping it in its original packaging, away from direct sunlight, extreme temperatures, and moisture until ready for use.

Is the Degania Low-Profile Gastrostomy Button MRI-safe?

The device is not inherently MRI-safe unless explicitly stated in the accompanying documentation. Patients and clinicians should verify compatibility with their MRI facility’s protocols before use, as silicone materials may react differently depending on the MRI machine’s specifications.

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: Degania Enteral Feeding | DSP Med, Low Profile Gastrostomy Feeding Tube or Gastrotomey Button, Adult gastrostomy tube - Degania Silicone - MedicalExpo, LOW PROFILE GASTROSTOMY FEEDING TUBE OR GASTROTOMEY… - FDA.report

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Degania Silicone Ltd
FDA Applicant
Degania Silicone , Ltd.

Sources (1)

  • FDA 510(k) K122030 24 fields · synced Oct 1, 2026