Modified Tfx Medical Safety Needle with Introducer

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K020985 ↗

FDA Product Code

KNT

Device Class

Class II

Regulation

21 CFR Part 876.5980

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Modified Tfx Medical Safety Needle with Introducer

  Class II

  FDA 510(k) K021034 Active Cleared 26 Jun 2002

• Tfx Medical Introducer Assembly

  Class II

  FDA 510(k) K993191 Active Cleared 24 Mar 2000

• Tfx Medical Safety Needle with Introducer

  Class II

  FDA 510(k) K000665 Active Cleared 2 May 2000

• What types of endoscopic procedures is this safety needle designed to assist with specifically?

  This safety needle with introducer is specifically designed for use during gastrointestinal endoscopic procedures, such as Percutaneous Endoscopic Gastrostomy (PEG) or Percutaneous Endoscopic Jejunostomy (PEJ). It facilitates the safe introduction of guidewires during these interventions, helping to ensure proper placement and reduce procedural risks.

• What sizes of guidewires can this device accommodate, and why is this important?

  This device is designed to accommodate guidewires ranging from 0.015 inches to 0.052 inches in diameter. This versatility is important because it allows clinicians to select the appropriate guidewire size for the specific patient anatomy and procedural requirements, ensuring compatibility and ease of use during PEG or PEJ procedures.

• Is this device reusable, or is it intended for single-use only? How does this affect its use in clinical settings?

  This device is intended for single-use only, which is explicitly stated in its design and regulatory documentation. This ensures sterility and reduces the risk of cross-contamination between patients, aligning with standard endoscopic safety protocols. Single-use also simplifies inventory management and disposal procedures in clinical settings.

• How is this device supplied, and what does the sterile packaging ensure for the clinician?

  The device is supplied sterile, meaning it is pre-packaged and prepared for immediate clinical use without additional sterilization. This ensures that clinicians can rely on a clean, uncontaminated instrument ready for insertion during procedures, minimizing the risk of infection and streamlining workflow.

• What regulatory pathway was followed for this device, and what does that mean for its use in hospitals?

  This device was cleared through the FDA 510(k) pathway (K020985) under a Traditional review, meaning it was determined to be substantially equivalent to a legally marketed predicate device. This clearance indicates that it meets FDA safety and effectiveness requirements for its intended use in endoscopic procedures, allowing hospitals to confidently incorporate it into their clinical protocols.