Stomach Tube Levin Tube
510(k) K831974
Active
Valid until
No expiry
FDA recalls
1 ongoingDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK831974 | Date18 Jul 1983 | StatusActive |
Recalls
-
- Ongoing Z-3008-2024
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
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
Overview
AI-generated summary, 19 Sep 2026
A Levin Stomach Tube is a flexible, single-lumen drainage tube designed for gastric decompression and feeding. It facilitates the removal of gastric contents and allows for the administration of liquids or medications directly into the stomach, aiding in patient care during surgical recovery, gastrointestinal obstruction, or other clinical conditions requiring gastric access.
The 14 Fr radiopaque vinyl tube measures 50" in length and includes marked insertion depth indicators at 18", 22", 26", and 30" to ensure proper placement. Supplied as a single-use, non-sterile device, it is intended for use in clinical settings where radiographic visualization is required. The beveled tip and staggered eyelets minimize trauma, while the flexible vinyl connector ensures unobstructed flow. Authorized under FDA 510(k) clearance (K831974)