Nutrisafe 2- ENFit Adaptor
FDA 510(k)Class II (US FDA 510(k))
by Vygon
Identifiers
- 510(k) Number
- K151237 FDA 510(k)
- FDA Product Code
- PIO 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- ENFit Adaptor is an enteral specific transition connector designed to interface between Nutrisafe2 and ENFit systems. It is classified as a Class II medical device under FDA regulation 876.5980 with product code PIO.
This adaptor is supplied non-sterile and intended for single use. It is used in clinical settings for neonatal and pediatric enteral feeding applications, particularly to prevent misconnection between enteral and parenteral systems. The device received FDA 510(k) clearance (K151237) on February 9, 2016, following a traditional review pathway with gastroenterology and urology advisory committee input.
Frequently asked questions
What is the Nutrisafe 2- ENFit Adaptor used for?
The Nutrisafe 2- ENFit Adaptor is used in clinical settings for neonatal and pediatric enteral feeding applications to interface between Nutrisafe2 and ENFit systems, specifically to prevent misconnection between enteral and parenteral systems.
Is the Nutrisafe 2- ENFit Adaptor sterile or non-sterile, and is it intended for single use or reuse?
The Nutrisafe 2- ENFit Adaptor is supplied non-sterile and is intended for single use only, as stated in the device description, to ensure patient safety and prevent cross-contamination in enteral feeding procedures.
What regulatory pathway and classification apply to the Nutrisafe 2- ENFit Adaptor?
The Nutrisafe 2- ENFit Adaptor is classified as a Class II medical device under FDA regulation 876.5980 with product code PIO, and it received FDA 510(k) clearance (K151237) via a traditional review pathway with input from gastroenterology and urology advisory committees.
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: nutrifit Adapter ENFit zu NS2 | Vygon, Safe Enteral Feeding Systems for Neonates & Preemies | Vygon, Nutrisafe2 for neonates & newborns - Safe Enteral
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K151237 | Class II | Active |
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Manufacturer
- Manufacturer
- Vygon
Sources (1)
- FDA 510(k) K151237 24 fields · synced Sep 27, 2026