Nutrisafe 2 Feeding Tubes Model 362.XXX, 1362.XXX
FDA 510(k)Class II (US FDA 510(k))
by Vygon Corp.
Identifiers
- 510(k) Number
- K100163 FDA 510(k)
- FDA Product Code
- FPD 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 Nutrisafe 2 Feeding Tubes are medical devices classified as feeding tubes intended for enteral nutrition. These tubes are designed for use in neonates, infants, and children to facilitate the delivery of nutrition.
The device is supplied by Vygon Corp. and has received FDA 510(k) clearance. It is available in various models and lengths to support enteral feeding practices.
Frequently asked questions
What is the intended use of Nutrisafe 2 Feeding Tubes?
These medical devices are specifically intended for enteral nutrition. They are designed to facilitate the delivery of nutrition to neonates, infants, and children.
What models are available for the Nutrisafe 2 Feeding Tubes?
The Nutrisafe 2 line includes various models and lengths to support different enteral feeding practices, specifically identified by the reference numbers 362.XXX and 1362.XXX.
Has this device received regulatory authorization?
Yes, the Nutrisafe 2 Feeding Tubes manufactured by Vygon Corp. have received FDA 510(k) clearance under the K-number K100163.
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: PVC feeding tubes - closed tip - Vygon, Safe Enteral Feeding Systems for Neonates & Preemies | Vygon, Nutrisafe 2 Feeding Tubes Model 362.xxx. 1362.xxx, Polyurethane feeding tubes - closed tip - Vygon USA
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K100163 | Class II | Active |
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Manufacturer
- Manufacturer
- Vygon Corp.
Sources (1)
- FDA 510(k) K100163 24 fields · synced Sep 21, 2026