đź“‹ FDA Reference
amsure hydrophilic latex foley catheter
Amsino International
Summary: The Amsure Hydrophilic Latex Foley Catheter is a medical device used for urinary drainage. It is commonly used by urologists and healthcare providers in hospitals and long-term care settings.
FDA Clearance Information
Pathway
510K
Number
K091699 ↗
Decision Date
August 10, 2009
Product Code
EZL
Device Class
Class 2
Evidence
419 studies
The Amsure Hydrophilic Latex Foley Catheter was cleared by the FDA via the 510(k) pathway on August 10, 2009. It is manufactured by Amsino International and is classified as a Class 2 device.
What It Is
The Amsure Hydrophilic Latex Foley Catheter is a urinary catheter designed for drainage of the bladder. It features a hydrophilic coating that reduces friction during insertion and removal, minimizing urethral irritation. This catheter is made of latex, which provides flexibility and durability, and is often used in patients requiring short- to medium-term catheterization.
Clinical Applications
This catheter is commonly used in urology, surgery, and critical care settings for patients who need urinary drainage due to urinary retention, post-surgical recovery, or other medical conditions affecting normal urination. It is suitable for use in both hospital and long-term care facilities, and is often utilized in adult patients who require catheterization for days to weeks.
Indications for Use
The FDA indications suggest this catheter is intended for patients who require bladder drainage. It is particularly useful for those with urinary retention or who are unable to void naturally due to medical conditions or surgical procedures.
Practical Considerations
The Amsure Hydrophilic Latex Foley Catheter is available in various sizes to accommodate different patient anatomies. It is important to ensure compatibility with the drainage system being used and to follow proper insertion techniques to minimize infection risk.
Related Literature
The linked study compared the Bardex Urinary Drainage System with a routine system using a silicone-coated latex Foley catheter. The study found that the Bardex system, with its hydrophilic coating and antiseptic application, reduced urethral irritation and bacterial migration. However, the study was limited by its focus on a specific system and may not directly apply to the Amsure catheter.
Linked Studies (20)
PubMed • 2025
Onyx Liquid Embolic Agent: Basic Knowledge for Its Use in Interventional Neuroradiology.
Journal of neuroendovascular therapy
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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
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PubMed • 2025
Clinical progress note: Haemophilus influenzae type b.
Journal of hospital medicine
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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
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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
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PubMed • 2025
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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PubMed • 2025
Tp40: a new potential prognostic and diagnostic marker for syphilis.
Microbiology spectrum
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PubMed • 2025
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
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
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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 the Amsure Hydrophilic Latex Foley Catheter used for?
It is used for urinary drainage in patients who cannot urinate naturally.
What specialties typically use this device?
Urology, surgery, and critical care specialties commonly use this catheter.
What are the FDA-cleared indications?
It is indicated for bladder drainage in patients with urinary retention or post-surgical needs.
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.