Ethix Feeding Tubes Polyurethane/Radiop.
by Ethox Corp. 510(k)
Active
510(k) K811639
Overview
The Ethix Feeding Tubes Polyurethane/Radiopaque are gastrointestinal tubes designed for enteral nutrition delivery. Constructed from polyurethane with radiopaque markers, these tubes facilitate precise placement within the digestive tract, enabling safe and effective feeding for patients requiring long-term nutritional support. Their radiopaque properties enhance visibility during fluoroscopic imaging, reducing the risk of misplacement. These tubes fall under the broader category of gastrointestinal tubes and accessories, serving critical roles in clinical nutrition and patient care.
These tubes are supplied as single-use medical devices, intended for use in clinical settings such as hospitals and outpatient care facilities. They are regulated under FDA 510(k) clearance (K811639) and classified under product code KNT, adhering to Special Controls for Class II devices. No information regarding MRI safety or reusable processing is provided in the specifications. Storage and handling should follow standard sterile medical device protocols to ensure integrity and safety prior to use.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK811639 | Date26 Jun 1981 | 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- Withdrawn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 Ethox Corp.
Questions
What are Ethix Polyurethane Radiopaque Feeding Tubes used for?
These tubes are designed for enteral nutrition delivery in patients requiring long-term nutritional support. Their polyurethane construction and radiopaque markers allow for safe, precise placement within the gastrointestinal tract, ensuring accurate feeding while minimizing the risk of misplacement during imaging.
Are Ethix Polyurethane Radiopaque Feeding Tubes reusable or single-use?
These tubes are intended for single-use only. They are supplied sterile and meant to be discarded after one use to maintain patient safety and device integrity, adhering to standard sterile medical device protocols.
How do the radiopaque markers improve safety during use?
The radiopaque markers embedded in the tubes enhance visibility under fluoroscopic imaging, allowing clinicians to confirm proper placement within the digestive tract. This reduces the risk of accidental misplacement, which can cause complications such as aspiration or intestinal perforation.
What regulatory approvals apply to these feeding tubes?
The Ethix Polyurethane Radiopaque Feeding Tubes hold FDA 510(k) clearance under the reference number K811639. They are classified under product code KNT and fall under Special Controls for Class II devices, ensuring compliance with U.S. medical device regulations.
How should these tubes be stored before use?
Storage should follow standard sterile medical device protocols to preserve integrity and safety. The tubes should be kept in their original, sealed packaging until immediately before use, protected from moisture, extreme temperatures, and physical damage to maintain sterility and functionality.