Moss Tubes All Silicone Gastrostomy Tube
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K984310 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)
The Moss Tubes All Silicone Gastrostomy Tube is a medical device classified as a gastrostomy tube (percutaneous endoscopic gastrostomy tube, PEG) designed for enteral feeding and gastric decompression. Constructed entirely of silicone, it provides a flexible, biocompatible pathway for nutrient delivery and gastric drainage, supporting long-term nutritional and hydration needs in patients requiring alternative feeding methods. Its triple-lumen design enhances functionality by enabling simultaneous feeding, decompression, and aspiration.
This device is supplied as a reusable medical product, intended for clinical use in hospital, home healthcare, or outpatient settings. The tube is non-sterile and must be sterilized prior to use, adhering to standard medical device reprocessing protocols. It is compatible with MRI environments and comes in standardized sizes tailored for pediatric and adult patients. Authorized under FDA 510K clearance (K984310), it complies with regulatory standards for gastrointestinal feeding and decompression devices.
Frequently asked questions
What is the Moss Tubes All Silicone Gastrostomy Tube used for?
This device is designed for enteral feeding and gastric decompression in patients requiring alternative nutrition or hydration. Its triple-lumen design allows simultaneous feeding, decompression, and aspiration, making it suitable for long-term clinical use in hospital, home healthcare, or outpatient settings.
Is the Moss Tubes All Silicone Gastrostomy Tube sterile?
No, the tube is supplied as non-sterile. It must be sterilized prior to use following standard medical device reprocessing protocols to ensure safety and effectiveness.
Can this tube be reused?
Yes, the Moss Tubes All Silicone Gastrostomy Tube is classified as a reusable medical product. It is intended for repeated clinical use after proper sterilization and reprocessing.
What sizes are available for the Moss Tubes All Silicone Gastrostomy Tube?
The tube comes in standardized sizes tailored for both pediatric and adult patients, though exact dimensions are not specified in the provided data. Always refer to the manufacturer’s sizing guide for precise fit.
Is the Moss Tubes All Silicone Gastrostomy Tube MRI-compatible?
Yes, the device is explicitly noted as compatible with MRI environments, making it suitable for patients who require imaging under these conditions.
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: Moss Tubes, Inc., Moss Gastrostomy Tube - Moss Tubes, Inc., Moss Tubes, Inc. - West Sand Lake, New York (NY) @ MedicRegister.com, Moss Tubes, Inc, All Silicone Gastrostomy Tube
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K984310 | Class II | Active |
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Manufacturer
- Manufacturer
- Moss Tubes, Inc.
Sources (1)
- FDA 510(k) K984310 24 fields · synced Oct 1, 2026