Vivonex Tungsten Tip Tube Placement
by Norwich Eaton Pharmaceuticals, Inc.
510(k) K821231
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK821231 | Date10 May 1982 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
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- Withdrawn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, 1 Oct 2026
The Vivonex Tungsten Tip Tube Placement is a Tube, Gastrointestinal (and Accessories) designed for the placement of feeding or drainage tubes within the gastrointestinal tract. Its tungsten-tipped design facilitates precise insertion through anatomical barriers, reducing trauma and improving accuracy during endoscopic or fluoroscopic guidance. The device is intended for use in procedures requiring controlled tube placement, such as nasogastric or nasojejunal intubation.
This device is supplied as a single-use medical instrument and is regulated under FDA 510(k) clearance (K821231) with a classification under Tubes, Gastrointestinal (and Accessories). It is intended for use in clinical settings such as hospitals or outpatient endoscopy suites, where sterility and precision are critical. No additional regulatory markings or MRI safety classifications are specified in the available data. The device is distributed by Norwich Eaton Pharmaceuticals, Inc., and its specifications align with traditional 510(k) clearance pathways.