Vivonex Tungsten Tip Tube-Braided
by Norwich Eaton Pharmaceuticals, Inc.
510(k) K831968
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK831968 | Date1 Sep 1983 | 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- Withdrawn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-Braided is a Tube, Gastrointestinal (and Accessories) designed for use in gastrointestinal and urological procedures. Its tungsten-tipped design provides radiopacity, enhancing visibility during fluoroscopic imaging for accurate placement within the body. The braided construction offers flexibility and durability, ensuring stability during insertion and use. This device is classified under the product code KNT and is intended for specialized medical applications requiring precise tubular access.
This device is supplied as a single-use medical instrument, intended for sterile use in clinical settings such as endoscopy or cystoscopy. It is not MRI-safe and must be handled with care to avoid damage to the tungsten tip or braided structure. Storage should follow manufacturer guidelines to maintain sterility and functionality. The device holds an FDA 510(k) clearance under the classification name Tubes, Gastrointestinal (and Accessories) with a decision of Substantially Equivalent (SESE), as documented in submission K831968.
Other devices from Norwich Eaton Pharmaceuticals, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the Vivonex Tungsten Tip Tube-Braided used for?
The Vivonex Tungsten Tip Tube-Braided is designed for gastrointestinal and urological procedures, such as endoscopy or cystoscopy. Its tungsten-tipped design provides radiopacity, making it visible under fluoroscopic imaging to ensure accurate placement within the body. The braided construction adds flexibility and durability, which helps maintain stability during insertion and use.
Is the Vivonex Tungsten Tip Tube-Braided single-use or reusable?
This device is intended for single-use only. It is supplied sterile for clinical use, meaning it should not be reused after a single procedure to maintain patient safety and sterility standards. Reuse could compromise the integrity of the tungsten tip or braided structure, potentially leading to inaccurate placement or procedural complications.
How should the Vivonex Tungsten Tip Tube-Braided be stored?
Storage must follow the manufacturer’s guidelines to preserve sterility and functionality. Since it is a single-use, sterile device, it should be stored in its original packaging until ready for use. Avoid exposure to moisture, extreme temperatures, or physical damage, particularly to the tungsten tip or braided section, as these could impair performance or visibility during procedures.
Is the Vivonex Tungsten Tip Tube-Braided MRI-safe?
No, the Vivonex Tungsten Tip Tube-Braided is not MRI-safe. The tungsten tip and braided construction contain materials that could pose risks in a magnetic resonance imaging environment, such as heating or displacement. Always verify compatibility with imaging modalities before use.
What distinguishes the Vivonex Tungsten Tip Tube-Braided from other tubes?
The key distinguishing features are its tungsten-tipped design for radiopacity and the braided construction for flexibility and durability. These attributes ensure visibility during fluoroscopic imaging and stability during insertion, which are critical for precise placement in gastrointestinal and urological procedures. The device is classified under product code KNT and holds FDA 510(k) clearance.