đź“‹ FDA Reference
aq hydrophilic urological catheters
Cook Urological
Summary: The aq hydrophilic urological catheters are used for atraumatic navigation of the urinary tract, primarily by urologists. They are designed to reduce friction during catheterization.
FDA Clearance Information
Pathway
510K
Number
K962004 ↗
Decision Date
June 11, 1996
Product Code
EYB
Device Class
Class 2
Evidence
419 studies
The aq hydrophilic urological catheters by Cook Urological were cleared via the FDA 510k pathway on June 11, 1996. They are classified as Class 2 medical devices.
What It Is
The aq hydrophilic urological catheters are designed to facilitate smooth navigation through the urinary tract by reducing friction. These catheters are coated with a hydrophilic material that becomes slippery when wet, minimizing trauma to the urethral and ureteral tissues during insertion and removal.
Clinical Applications
These catheters are commonly used in urological procedures, such as catheterization for urinary retention or drainage, and during diagnostic procedures like cystoscopy. They are typically used in hospital settings, outpatient clinics, and by urologists for patients requiring catheterization due to urinary tract obstructions or postoperative care.
Indications for Use
These catheters are indicated for use in patients who require catheterization for urinary drainage or management of urinary tract obstructions. They are suitable for patients with conditions that necessitate reduced friction during catheterization.
Practical Considerations
The catheters are available in various sizes to accommodate different patient anatomies. They are compatible with standard urological instruments and should be handled with care to maintain the integrity of the hydrophilic coating.
Related Literature
The linked study compared the frictional forces of various ureteral access sheaths and dilators, including hydrophilic urological catheters, using a porcine ureteral model. It found that hydrophilic coatings significantly reduce friction during catheterization. However, the study's limitations include its ex vivo nature and the use of animal models, which may not fully replicate human anatomy.
Linked Studies (20)
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Onyx Liquid Embolic Agent: Basic Knowledge for Its Use in Interventional Neuroradiology.
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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
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PubMed • 2025
Clinical progress note: Haemophilus influenzae type b.
Journal of hospital medicine
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Pilot study of social media promotion of home-based self-testing for syphilis.
Sexually transmitted diseases
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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
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Implementation of an Opt-Out and Rapid Point-of-Care Syphilis Testing Program for Pregnant Patients Presenting to the Emergency Department.
Sexually transmitted diseases
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PubMed • 2025
Evaluation of Rapid Syphilis Testing Using the Syphilis Health Check in Florida, 2015-2016.
Florida public health review
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Multiplex droplet digital PCR for the detection and quantitation of Streptococcus pneumoniae, Mycoplasma pneumoniae, and Haemophilus influenzae.
Frontiers in cellular and infection microbiology
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Palm Multidiagnostic of Mycoplasma pneumoniae, Chlamydia pneumoniae, Haemophilus influenzae, and Streptococcus pneumoniae Using One-Tube CRISPR/Cas12a.
Transboundary and emerging diseases
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Tp40: a new potential prognostic and diagnostic marker for syphilis.
Microbiology spectrum
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Serotonin sets up neutrophil extracellular traps to promote neuroendocrine prostate cancer metastasis in the liver.
The Journal of clinical investigation
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PubMed • 2025
Application value of Philips Ingenuity TF PET/CT scanner imaging agent FAP in evaluating renal fibrosis.
Hellenic journal of nuclear medicine
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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
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PubMed • 2025
Improved patient comfort and procedural efficiency using chlorhexidine-coated hydrophilic urethral catheters: a randomized controlled trial.
Journal of Yeungnam medical science
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PubMed • 2025
pTx-Pulseq in hybrid sequences: Accessible and advanced hybrid open-source MRI sequences on Philips scanners.
Magnetic resonance in medicine
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PubMed • 2025
Comparative connectomics of Drosophila descending and ascending neurons.
Nature
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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 is aq hydrophilic urological catheters used for?
They are used for reducing friction during urinary catheterization, aiding in atraumatic navigation of the urinary tract.
What specialties typically use this device?
Urologists primarily use these catheters in both hospital and outpatient settings.
What are the FDA-cleared indications?
They are indicated for catheterization in patients requiring urinary drainage or management of urinary tract obstructions.
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.