Esophageal Tube
by E. Benson Hood Laboratories, Inc. 510(k)
Active
510(k) K841349
Overview
The Esophageal Reconstruction Tube is a medical device classified as a Tube, Laryngectomy under the product code KNT. It is designed for use in esophageal reconstruction procedures, specifically to manage salivary leakage through a pharyngostoma while maintaining a patent lumen for subsequent surgical stages. The device facilitates the creation of a trough between the pharyngostoma and esophagostoma, aiding in the preparation for the second-stage reconstruction.
This device is supplied as a reusable medical instrument and is intended for use in controlled clinical settings, such as operating rooms or surgical recovery areas. It is not sterile at the time of shipment but is intended to be sterilized prior to use, adhering to standard medical device sterilization protocols. The Esophageal Reconstruction Tube ERT-14 holds an FDA 510(k) clearance under K-number K841349, with a decision date of July 23, 1984. No specific MRI safety information is provided, and its dimensions or additional technical specifications are not detailed in the available data.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK841349 | Date23 Jul 1984 | 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- Withdrawn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 E. Benson Hood Laboratories, Inc.
Questions
What is the ERT-14 Esophageal Reconstruction Tube used for in surgery?
The ERT-14 Esophageal Reconstruction Tube is designed specifically for esophageal reconstruction procedures. It helps manage salivary leakage through a pharyngostoma while keeping the lumen open for subsequent surgical steps. By creating a trough between the pharyngostoma and esophagostoma, it prepares the site for the second-stage reconstruction, ensuring controlled fluid drainage and structural support during the process.
Is the ERT-14 Esophageal Reconstruction Tube single-use or reusable?
The ERT-14 Esophageal Reconstruction Tube is supplied as a reusable medical instrument. It is intended for use in controlled clinical settings like operating rooms or surgical recovery areas, where it can be sterilized between procedures following standard medical device sterilization protocols. This design allows for repeated use after proper cleaning and sterilization.
Is the ERT-14 Esophageal Reconstruction Tube sterile upon arrival?
No, the ERT-14 Esophageal Reconstruction Tube is not sterile at the time of shipment. It must be sterilized prior to use in accordance with standard medical device sterilization protocols to ensure safety and efficacy in clinical settings.
What clinical settings is the ERT-14 Esophageal Reconstruction Tube intended for?
The ERT-14 is intended for use in controlled clinical environments such as operating rooms or surgical recovery areas. These settings provide the necessary conditions for proper sterilization, handling, and monitoring required for its use in esophageal reconstruction procedures.
Does the ERT-14 Esophageal Reconstruction Tube have any specific MRI safety information?
The available data does not provide any specific MRI safety information for the ERT-14 Esophageal Reconstruction Tube. Clinicians should exercise caution and consult manufacturer guidelines or additional documentation if MRI compatibility is a concern for a particular patient or procedure.