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Entuit Nasal Jejunal Feeding Tube

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K201322

by Wilson-Cook Medical, Inc.

Identifiers

510(k) Number
K201322 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 Entuit Nasal Jejunal Feeding Tube is a nasal jejunal feeding tube designed for enteral nutrition delivery, providing short-term access to the small bowel via the nasal route. It facilitates the administration of liquids, nutrients, or medications directly into the jejunum, bypassing the stomach for targeted therapeutic support in patients requiring specialized nutritional intervention.

This device is supplied as a single-use, sterile product and is intended for use in clinical settings such as hospitals or outpatient care. It is regulated under FDA 510(k) clearance (K201322) and MDD compliance, with model-specific variants like the NJFT-10 noted in recall advisories. Storage and handling must adhere to manufacturer guidelines to maintain sterility and functionality, ensuring safe clinical application.

Frequently asked questions

What clinical scenarios is the Entuit Nasal Jejunal Feeding Tube designed to address?

The Entuit Nasal Jejunal Feeding Tube is specifically designed for patients who require enteral nutrition delivered directly to the jejunum, bypassing the stomach. This is particularly useful for individuals with conditions that impair gastric emptying, such as severe gastroparesis, or those who need targeted nutrient delivery to the small intestine for better absorption or therapeutic support. It is intended for short-term use in clinical settings like hospitals or outpatient care.

Is the Entuit Nasal Jejunal Feeding Tube meant for repeated use, or is it single-use only?

The Entuit Nasal Jejunal Feeding Tube is explicitly supplied as a single-use, sterile product. This design ensures patient safety by preventing cross-contamination and maintaining sterility, which is critical for enteral feeding applications where infection control is paramount. After use, the tube should be discarded according to manufacturer guidelines.

How should I store the Entuit Nasal Jejunal Feeding Tube to ensure it remains effective and sterile?

To maintain sterility and functionality, the tube must be stored following the manufacturer’s guidelines, which are detailed in the accompanying documentation. Typically, this involves keeping it in its original, sealed packaging in a clean, dry environment away from direct sunlight or extreme temperatures. Avoiding contamination and ensuring the packaging remains intact until use is essential for preserving its sterile condition.

What regulatory pathways has the Entuit Nasal Jejunal Feeding Tube undergone, and how does this affect its use?

The Entuit Nasal Jejunal Feeding Tube has undergone FDA 510(k) clearance (K201322) and complies with the Medical Device Directive (MDD). These regulatory pathways confirm that the device meets established safety and performance standards for its intended use. Clinicians and buyers can rely on this clearance to ensure the tube adheres to necessary guidelines for clinical application, though local regulations may still apply depending on the jurisdiction.

Are there different sizes or models of the Entuit Nasal Jejunal Feeding Tube, and if so, what should I consider when selecting one?

While the specifications provided mention a model-specific variant like the NJFT-10, which has been referenced in recall advisories, the exact sizing details (e.g., French gauge, length, or lumen diameter) are not explicitly outlined in the data. When selecting a model, you should refer to the manufacturer’s catalog or consult with a healthcare professional to ensure the chosen tube matches the patient’s anatomical needs and clinical requirements. Always verify compatibility with the patient’s condition and the intended feeding protocol.

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: Nasal Jejunal Feeding Tube - Cook Medical, Entuit Nasal Jejunal Feeding Tube (K201322) - FDA 510 (k), Entuit® Feeding Tubes | Cook Medical, Wilson-Cook Nasal Jejunal Feeding Tube Recall - Wilson-Cook Medical Inc ...

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDD

United States Active

FDA_510K

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Manufacturer

Manufacturer
Wilson-Cook Medical, Inc.

Sources (2)

  • FDA 510(k) K201322 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 18, 2026