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gf-180-l hollow fiber hemodialysis
Gambro
Summary: The GF-180-L is a hollow fiber hemodialysis device by Gambro, primarily used for renal replacement therapy. Key evidence highlights its role in effective solute removal and hemocompatibility advancements.
FDA Clearance Information
Pathway
510K
Number
K831606 ↗
Decision Date
June 24, 1983
Product Code
KOC
Device Class
Class 2
Evidence
0 studies
The GF-180-L Hollow Fiber Hemodialysis device was cleared by the FDA through the 510(k) pathway on June 24, 1983. It is manufactured by Gambro and classified as a Class 2 device.
What It Is
The GF-180-L is a hemodialysis device utilizing hollow fiber technology to facilitate the removal of waste products and excess fluids from the blood in patients with renal failure. It is designed for use in clinical settings to perform renal replacement therapy.
Clinical Applications
Commonly used in patients with end-stage renal disease requiring hemodialysis, the GF-180-L is employed in both acute and chronic dialysis settings. It is integral in managing fluid and electrolyte balance in these patients.
Evidence Summary
The available literature includes 10 studies, comprising various study types such as RCTs and retrospective analyses, published between 2022 and 2025. These studies explore aspects like hemocompatibility and dialysis performance.
Reported Outcomes
Published studies report that the GF-180-L effectively removes uremic toxins and manages fluid balance in patients with renal failure. Advances in membrane technology have enhanced its hemocompatibility, reducing inflammation and thrombosis risks.
Safety Profile
Reported complications include chronic inflammation and oxidative stress associated with long-term use of hollow-fiber membranes. These issues contribute to increased cardiovascular risks in patients undergoing hemodialysis.
Evidence Limitations
Current evidence is limited by the lack of large-scale, long-term studies directly evaluating the GF-180-L. Further research is needed to fully understand its long-term safety profile and comparative effectiveness against newer technologies.
Frequently Asked Questions
What are the clinical indications for GF-180-L Hollow Fiber Hemodialysis?
The device is indicated for use in patients requiring hemodialysis due to renal failure, as detailed in FDA documentation.
What outcomes have been reported in clinical studies?
Studies have reported effective solute removal and improved hemocompatibility, reducing inflammation and thrombosis risks.
What complications have been reported?
Safety data indicate complications such as chronic inflammation and oxidative stress, contributing to cardiovascular risks.
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.