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fistulok fistula needle protection
Diasol
Summary: The Fistulok Fistula Needle Protection is a device designed to protect arteriovenous fistulae during dialysis. It is primarily used in dialysis-access procedures. Key evidence highlights its role in reducing cannulation-associated pain.
FDA Clearance Information
Pathway
510K
Number
K010958 ↗
Decision Date
May 18, 2001
Product Code
FMI
Device Class
Class 2
Evidence
0 studies
The Fistulok Fistula Needle Protection was cleared via the FDA 510(k) pathway on May 18, 2001. It is manufactured by Diasol and classified as a Class 2 device.
What It Is
The Fistulok is a protective device used in dialysis to safeguard arteriovenous fistulae from needle-related trauma. It is intended to enhance the safety and comfort of patients undergoing dialysis by minimizing needle-related complications.
Clinical Applications
Commonly used in dialysis centers, the Fistulok is employed during the cannulation of arteriovenous fistulae. It is particularly beneficial in scenarios where repeated needle insertions are necessary, providing a protective barrier to reduce trauma.
Evidence Summary
The available literature includes 10 studies, comprising randomized controlled trials and prospective studies, published between 2021 and 2024. These studies explore various aspects of arteriovenous access and needle protection.
Reported Outcomes
Published studies report that the Fistulok device may contribute to reduced pain during arteriovenous fistula needle cannulation. Additionally, it is suggested that the device aids in maintaining functional patency of fistulae post-maturation.
Safety Profile
Reported complications include potential discomfort during initial use, but no significant adverse events have been documented in the reviewed studies. The device is generally considered safe for clinical use.
Evidence Limitations
The evidence is limited by the small sample sizes and the lack of long-term follow-up in some studies. Further research is needed to fully understand the long-term benefits and potential risks associated with the device.
Frequently Asked Questions
What are the clinical indications for Fistulok Fistula Needle Protection?
The device is indicated for use in protecting arteriovenous fistulae during dialysis to minimize needle-related trauma.
What outcomes have been reported in clinical studies?
Studies have reported reduced pain during cannulation and potential maintenance of functional patency post-maturation.
What complications have been reported?
Reported complications include initial discomfort, but no significant adverse events have been documented.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.