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Greco-Harvey Surfactant Bonded Catheter for Gastro
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 ?
510(k)
Number ?
K851242 ↗
Decision Date ?
September 11, 1985
Product Code ?
FGE Stents, Drains And Dilators For The Biliary Ducts
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.
FDA-Cleared Indications
- Use in gastroenterological procedures involving drainage or catheter access of the biliary ductal system, consistent with FDA product code FGE.
- The specific indication should be confirmed in the original 510(k) clearance and current manufacturer labeling before clinical use.
Clinical Applications
- Biliary duct drainage or catheter access when a device in the FDA-cleared biliary drainage category is indicated.
- Gastroenterological procedures requiring temporary catheter placement in the biliary system.
- Use in situations where the catheter's surfactant-bonded surface is intended to reduce microbial adhesion.
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.
Practical Considerations
- Confirm the catheter's available diameter, length, configuration, and working-channel requirements in the current Cook labeling.
- Use compatible guidewires, introducers, drainage systems, and accessories specified by the manufacturer.
- The surfactant-bonded surface does not eliminate infection risk; sterile technique, appropriate drainage management, and clinical monitoring remain necessary.
- MRI safety is not established by the information provided. Review the device's current MRI labeling before MRI exposure.
- Contraindications, warnings, and dwell time should be taken from the original FDA labeling and current instructions for use; do not assume that the catheter is appropriate for every gastrointestinal or biliary procedure.
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.