đź“Š Evidence-Based Reference
ercp catheter hydrophilic coated
Wilson-Cook Medical
Summary: The ERCP catheter with hydrophilic coating by Wilson-Cook Medical is designed for endoscopic retrograde cholangiopancreatography. Key evidence highlights its use in reducing bacterial adhesion compared to silicone catheters.
FDA Clearance Information
Pathway 510K
Number K932205 ↗
Decision Date January 3, 1994
Product Code GBX
Device Class Class 1
Evidence 419 studies
The ERCP catheter hydrophilic coated was cleared by the FDA via the 510(k) pathway on January 3, 1994. It is manufactured by Wilson-Cook Medical and classified as a Class 1 device under product code GBX.
What It Is
The ERCP catheter with hydrophilic coating is used in endoscopic procedures to access the biliary and pancreatic ducts. Its hydrophilic coating is intended to reduce friction and bacterial adhesion, facilitating smoother catheter insertion and reducing infection risk.
Clinical Applications
This device is commonly used in procedures requiring access to the bile or pancreatic ducts, such as in the management of malignant obstructive jaundice. It is particularly useful in scenarios where reduced bacterial adhesion is desired.
Evidence Summary
The available literature includes two studies from 1986 and 1997. These studies explore the catheter's design and its effects on bacterial adhesion, with one study being a randomized controlled trial.
Reported Outcomes
Published studies report that the hydrophilic heparinized catheter shows reduced bacterial adhesion compared to silicone catheters in patients with malignant obstructive jaundice. The everting catheter design also demonstrates enhanced lubricity.
Safety Profile
Reported complications include potential bacterial colonization, although the hydrophilic coating is designed to mitigate this risk. No specific adverse events were detailed in the provided studies.
Evidence Limitations
The evidence is limited by the small number of studies and the lack of recent data. Further research is needed to confirm long-term safety and efficacy, as well as to explore additional clinical applications.
Linked Studies (20)
PubMed • 2025
Onyx Liquid Embolic Agent: Basic Knowledge for Its Use in Interventional Neuroradiology.
Journal of neuroendovascular therapy
RCT|prospective|retrospective|case Series|other View Source → PubMed • 2025
Performance evaluation of quantitative hemoglobin A2 and fetal hemoglobin testing using commercially lyophilized vs. in-house whole blood controls in Chinese clinical laboratories: a 12-year analysis of National External Quality Assessment Data.
Clinical chemistry and laboratory medicine
RCT|prospective|retrospective|case Series|other View Source → PubMed • 2025
Clinical progress note: Haemophilus influenzae type b.
Journal of hospital medicine
RCT|prospective|retrospective|case Series|other View Source → PubMed • 2025
Pilot study of social media promotion of home-based self-testing for syphilis.
Sexually transmitted diseases
RCT|prospective|retrospective|case Series|other View Source → PubMed • 2025
Clinical development and performance of the First to Know Syphilis Self-Test for over-the-counter usage: a de novo rapid test for treponemal antibody.
Journal of clinical microbiology
View Source → PubMed • 2025
Implementation of an Opt-Out and Rapid Point-of-Care Syphilis Testing Program for Pregnant Patients Presenting to the Emergency Department.
Sexually transmitted diseases
RCT|prospective|retrospective|case Series|other View Source → PubMed • 2025
Evaluation of Rapid Syphilis Testing Using the Syphilis Health Check in Florida, 2015-2016.
Florida public health review
View Source → PubMed • 2025
Multiplex droplet digital PCR for the detection and quantitation of Streptococcus pneumoniae, Mycoplasma pneumoniae, and Haemophilus influenzae.
Frontiers in cellular and infection microbiology
RCT|prospective|retrospective|case Series|other View Source → PubMed • 2025
Palm Multidiagnostic of Mycoplasma pneumoniae, Chlamydia pneumoniae, Haemophilus influenzae, and Streptococcus pneumoniae Using One-Tube CRISPR/Cas12a.
Transboundary and emerging diseases
View Source → PubMed • 2025
Tp40: a new potential prognostic and diagnostic marker for syphilis.
Microbiology spectrum
View Source → PubMed • 2025
Serotonin sets up neutrophil extracellular traps to promote neuroendocrine prostate cancer metastasis in the liver.
The Journal of clinical investigation
RCT|prospective|retrospective|case Series|other View Source → PubMed • 2025
Application value of Philips Ingenuity TF PET/CT scanner imaging agent FAP in evaluating renal fibrosis.
Hellenic journal of nuclear medicine
RCT|prospective|retrospective|case Series|other View Source → PubMed • 2025
Message from Dr. Philippe T. Georgel, Guest Editor for the Marshall University Collection, Brad D. Smith, President of Marshall University, and Dr. Anivandan Mukherjee, Provost of Marshall University.
Biochemistry and cell biology = Biochimie et biologie cellulaire
View Source → PubMed • 2025
Improved patient comfort and procedural efficiency using chlorhexidine-coated hydrophilic urethral catheters: a randomized controlled trial.
Journal of Yeungnam medical science
RCT View Source → PubMed • 2025
pTx-Pulseq in hybrid sequences: Accessible and advanced hybrid open-source MRI sequences on Philips scanners.
Magnetic resonance in medicine
RCT|prospective|retrospective|case Series|other View Source → PubMed • 2025
Comparative connectomics of Drosophila descending and ascending neurons.
Nature
RCT|prospective|retrospective|case Series|other View Source → PubMed • 2025
Hydrophilic-coated sheaths for reducing radial artery spasm during transradial procedures: A systematic review and meta-analysis.
Interventional neuroradiology : journal of peritherapeutic neuroradiology, surgical procedures and related neurosciences
View Source → PubMed • 2025
History of antineutrophil cytoplasmic autoantibodies : Milestones in rheumatology.
Zeitschrift fur Rheumatologie
View Source → PubMed • 2025
A Hydrophilic Polyurethane Foam Containing Nigella sativa Oil as a Wound Dressing.
BioMed research international
RCT|prospective|retrospective|case Series|other View Source →Frequently Asked Questions
What are the clinical indications for ERCP catheter hydrophilic coated?
The device is indicated for use in endoscopic procedures requiring access to the biliary and pancreatic ducts, particularly in cases of malignant obstructive jaundice.
What outcomes have been reported in clinical studies?
Studies report reduced bacterial adhesion with the hydrophilic catheter compared to silicone catheters, enhancing procedural safety.
What complications have been reported?
Safety data indicate potential bacterial colonization, although the hydrophilic coating aims to reduce this risk.
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.