Modified Tfx Medical Safety Needle with Introducer
by Tfx Medical, Inc. 2 variants
510(k) K021034
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK021034 | Date26 Jun 2002 | 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- Withdrawn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
This device is a safety needle with introducer designed for guidewire placement during gastrointestinal procedures. It is classified under the needle, safety category and incorporates a protective sheath to reduce the risk of needle-stick injuries while facilitating the insertion of guidewires ranging from 0.015″ to 0.052″ in diameter. The introducer component ensures controlled access for the guidewire, enhancing procedural safety and precision in applications such as Percutaneous Endoscopic Gastrostomy (PEG) or Percutaneous Endoscopic Jejunostomy (PEJ).
The Modified TFX Medical Safety Needle With Introducer (T4634-02) is intended for single-use in endoscopic gastrointestinal procedures. It is supplied sterile and requires no additional sterilization before use. The device is non-MRI-safe and must be handled with care to avoid contamination. Storage should follow manufacturer guidelines to maintain sterility and functionality. This product holds FDA 510(k) clearance under the K021034 classification, ensuring compliance with regulatory standards for medical devices.
Other devices from Tfx Medical, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the TFX Safety Needle With Introducer (T4634-02) used for?
This device is designed specifically for guidewire placement during gastrointestinal procedures, such as Percutaneous Endoscopic Gastrostomy (PEG) or Percutaneous Endoscopic Jejunostomy (PEJ). The protective sheath and introducer component help control access, reducing the risk of needle-stick injuries while ensuring precise guidewire insertion for safer procedures.
How is the TFX Safety Needle With Introducer (T4634-02) supplied and prepared for use?
The device is supplied sterile and ready for immediate single-use in endoscopic procedures. No additional sterilization is required before use, as it is intended for one-time application only. Always follow manufacturer guidelines to maintain sterility and functionality during storage.
What guidewire sizes does the TFX Safety Needle With Introducer accommodate?
This device is compatible with guidewires ranging from 0.015 inches to 0.052 inches in diameter. The introducer component is engineered to provide controlled access, ensuring the guidewire can be inserted safely and accurately during procedures.
Is the TFX Safety Needle With Introducer (T4634-02) MRI-safe?
No, the TFX Safety Needle With Introducer (T4634-02) is explicitly labeled as non-MRI-safe. This means it should not be used in or near MRI equipment, as it could pose risks during imaging procedures.
How should the TFX Safety Needle With Introducer (T4634-02) be stored to preserve its integrity?
To maintain sterility and functionality, storage should adhere strictly to the manufacturer’s guidelines. The device should be kept in its original packaging until ready for use, protected from contamination, and stored in a clean, dry environment away from direct sunlight or extreme temperatures.