đź“‹ FDA Reference
Aq Hydrophilic Stent
Cook Urological
Summary: The AQ Hydrophilic Stent is a medical device used primarily in urology to facilitate urine flow in patients with urinary tract obstructions. It is used by urologists in both hospital and outpatient settings.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K961446 ↗
Decision Date ?
May 28, 1996
Product Code ?
FAD
Device Class ?
Class 2
Evidence ?
419 studies
The AQ Hydrophilic Stent was cleared through the FDA 510(k) pathway on May 28, 1996. It is manufactured by Cook Urological and classified as a Class 2 medical device.
What It Is
The AQ Hydrophilic Stent is a ureteral stent designed to maintain patency in the urinary tract, allowing urine to flow from the kidney to the bladder. Its hydrophilic coating reduces friction, facilitating easier insertion and removal. This device is particularly useful in managing ureteral obstructions due to stones, tumors, or strictures.
FDA-Cleared Indications
- Drainage of urine through an obstructed ureter
- Maintaining ureteral patency when urinary flow from the kidney to the bladder is impaired
Clinical Applications
- Temporary ureteral drainage in patients with urinary tract obstruction
- Ureteral stenting for obstruction associated with urinary stones
- Ureteral stenting for obstruction caused by ureteral strictures
- Ureteral stenting when postoperative swelling impairs urine flow
Practical Considerations
- The stent is available in different lengths and diameters; selection depends on patient anatomy and the location and cause of obstruction.
- The hydrophilic coating is activated with sterile water according to the device instructions before insertion.
- Placement and removal are performed with standard urological techniques and imaging or endoscopic guidance as appropriate.
- MRI safety depends on the exact device materials and labeling; the specific product instructions should be reviewed before MRI.
- Contraindications and precautions include inability to safely access the ureter, untreated urinary infection, or anatomy that prevents appropriate stent placement; the treating urologist should review the current labeling.
Related Literature
The linked study explored a novel alginate-quercetin ureteral stent formulation, assessing its mechanical properties and biocompatibility. Key findings included satisfactory tensile strength and non-cytotoxicity against human ureteral cells. However, the study's limitation is its focus on a new formulation not directly related to the AQ Hydrophilic Stent.
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 is the AQ Hydrophilic Stent used for?
It is used to maintain urine flow in patients with urinary tract obstructions.
What specialties typically use this device?
Urologists commonly use this device in both hospital and outpatient settings.
What are the FDA-cleared indications?
The device is indicated for use in patients with urinary tract obstructions, such as those caused by kidney stones or strictures.
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.