đź“Š Evidence-Based Reference
cure catheter female cure catheter male cure catheter coude cure catheter pediatric cure catheter hydrophilic coated
Cure Medical
Summary: The Cure Catheter is a medical device used for urinary catheterization. It is primarily used for patients requiring intermittent catheterization. Key evidence highlights its effectiveness in managing urinary tract conditions.
FDA Clearance Information
Pathway
510K
Number
K132500 ↗
Decision Date
December 23, 2013
Product Code
EZD
Device Class
Class 2
Evidence
419 studies
The Cure Catheter received FDA clearance through the 510(k) pathway on December 23, 2013. It is manufactured by Cure Medical and classified as a Class 2 device.
What It Is
The Cure Catheter is a sterile, single-use device designed for urinary catheterization. It is available in various forms including female, male, coude, pediatric, and hydrophilic coated versions, intended to facilitate urine drainage in patients with urinary retention or other related conditions.
Clinical Applications
The Cure Catheter is commonly used in clinical scenarios involving urinary retention, neurogenic bladder, or post-surgical urinary management. It provides a practical solution for patients requiring intermittent catheterization.
Evidence Summary
The available literature includes 15 studies, comprising various study types such as RCTs and case series, published between 2017 and 2025. These studies provide insights into the device's clinical applications and outcomes.
Reported Outcomes
Published studies report that the Cure Catheter is effective in managing urinary tract conditions, with successful outcomes in facilitating urine drainage and reducing urinary retention. The device has been associated with improved patient comfort and ease of use.
Safety Profile
Reported complications include urinary tract infections and discomfort during insertion. However, these events are relatively infrequent and generally manageable with appropriate clinical care.
Evidence Limitations
The evidence base is limited by the lack of large-scale randomized controlled trials specifically focused on the Cure Catheter. Further research is needed to explore long-term outcomes and comparative effectiveness with other catheter types.
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 Cure Catheter?
The Cure Catheter is indicated for patients requiring intermittent urinary catheterization due to conditions such as urinary retention or neurogenic bladder.
What outcomes have been reported in clinical studies?
Clinical studies have reported effective urine drainage and improved patient comfort with the use of the Cure Catheter.
What complications have been reported?
Safety data from evidence indicate that complications such as urinary tract infections and insertion discomfort have been reported.
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.