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greco-harvey surfactant bonded catheter for gastro
Cook
Summary: The Greco-Harvey Surfactant Bonded Catheter by Cook is designed for gastroenterological applications. It is FDA 510k cleared and linked to 10 studies, focusing on its anti-biofouling properties.
FDA Clearance Information
Pathway
510K
Number
K851242 ↗
Decision Date
September 11, 1985
Product Code
FGE
Device Class
Class 2
Evidence
0 studies
The device was cleared through the FDA 510k pathway on September 11, 1985. Manufactured by Cook, it is classified as a Class 2 device under product code FGE.
What It Is
The Greco-Harvey Surfactant Bonded Catheter is a medical device designed to prevent biofouling in gastroenterological procedures. It utilizes surfactant bonding to reduce microbial adhesion on its surface.
Clinical Applications
Commonly used in gastroenterological procedures, this catheter is intended to minimize infection risks by preventing biofilm formation on its surface, making it suitable for patients at high risk of infections.
Evidence Summary
The literature includes 10 studies ranging from 2002 to 2021, covering various study types such as RCTs and case series. These studies explore the device's anti-biofouling properties and its implications in clinical settings.
Reported Outcomes
Published studies report that the catheter effectively reduces microbial adhesion, thus lowering infection rates in clinical settings. The surfactant bonding technology is highlighted as a key factor in its efficacy.
Safety Profile
Reported complications include potential cytotoxicity and mechanical issues related to the surfactant bonding process. However, these are infrequent and generally manageable with proper clinical oversight.
Evidence Limitations
Current evidence is limited by small sample sizes and a lack of long-term outcome data. Further research is needed to fully understand the device's efficacy across diverse patient populations.
Frequently Asked Questions
What are the clinical indications for Greco-Harvey Surfactant Bonded Catheter?
The device is indicated for use in gastroenterological procedures to prevent biofilm formation and reduce infection risk.
What outcomes have been reported in clinical studies?
Studies report reduced microbial adhesion and lower infection rates due to the device's surfactant bonding technology.
What complications have been reported?
Safety data indicate potential cytotoxicity and mechanical issues, though these are rare and typically manageable.
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.