Enternal Feeding Tube-Polyurethane EF504
by Exco, Inc. 510(k)
Active
510(k) K844175
Overview
The Enteral Feeding Tube – Polyurethane EF504 is a gastrointestinal tube designed for enteral nutrition delivery. Constructed from polyurethane, it is intended for insertion into the stomach or small intestine to provide liquid nutritional support when oral intake is inadequate.
This single-use device is supplied sterile and falls under the classification of Tubes, Gastrointestinal (and Accessories). It was cleared under the FDA’s 510(k) pathway as substantially equivalent to a predicate device, with regulatory filing completed in 1985. The device is intended for use in clinical settings such as gastroenterology and urology procedures.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK844175 | Date2 Jan 1985 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- KNT
- Device Class
- Class II
- Regulation
- 21 CFR Part 876.5980
- Advisory Committee
- Gastroenterology, Urology
- FDA Decision
- SESE Substantially Equivalent
Other devices from Exco, Inc.
Questions
What clinical specialties commonly use this enteral feeding tube, and why is it suited for those fields?
This polyurethane enteral feeding tube (EF504) is primarily used in gastroenterology and urology settings. It is designed for enteral nutrition delivery when oral intake is insufficient, making it ideal for patients requiring long-term or short-term nutritional support via the stomach or small intestine. Its sterile, single-use nature and durable polyurethane construction ensure reliability in clinical procedures where hygiene and patient safety are critical.
Is this feeding tube reusable, or is it meant for one-time use only? How does that affect its clinical use?
This device is explicitly labeled as single-use only, meaning it is intended for one-time insertion and use per patient. This design choice ensures sterility and reduces the risk of contamination or infection, which is particularly important in enteral nutrition where patient safety is paramount. Reuse is not recommended, as it could compromise the tube’s integrity or introduce pathogens.
How is the Enteral Feeding Tube – Polyurethane EF504 supplied, and what does ‘sterile’ mean in this context?
The tube is supplied sterile, meaning it undergoes manufacturing processes to eliminate or deactivate microorganisms, ensuring it is free from contamination before use. This is critical for enteral feeding to prevent infections in vulnerable patients. The ‘sterile’ designation applies to the packaging and shelf-life as indicated by the manufacturer, so clinicians should follow the provided storage instructions to maintain sterility until use.
What regulatory pathway was followed for this device, and when was it cleared by the FDA?
This device was cleared through the FDA’s 510(k) pathway, which demonstrates it is substantially equivalent to a predicate device already on the market. The regulatory filing was received on October 25, 1984, and the clearance decision was made on January 2, 1985, under the classification of Tubes, Gastrointestinal (and Accessories). This means it meets FDA standards for safety and effectiveness as determined by the agency.