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cure catheter insertion kit k1 cure catheter insertion kit k2 cure catheter insertion kit k2-90 cure catheter insertion kit k3 cure hydrophilic catheter kit hm12uk cure hydrophilic catheter kit hm14uk cure hydrophilic catheter kit hm16uk cure pocket catheter kit m14uk cure catheter closed system kit cs8 cure catheter closed system kit cs10 cure catheter closed system kit cs12 cure catheter closed system kit cs14 cure catheter closed system kit cs14c
Convatec
Summary: The Cure Catheter Kits by Convatec are medical devices used for urinary catheterization. They are designed for use by healthcare professionals in various clinical settings to manage urinary retention or incontinence.
FDA Clearance Information
Pathway
510K
Number
K250891 ↗
Decision Date
June 6, 2025
Product Code
FCM
Device Class
Class 2
Evidence
419 studies
The Cure Catheter Kits by Convatec were cleared through the FDA 510k pathway on June 6, 2025. They are classified as Class 2 medical devices under product code FCM.
What It Is
The Cure Catheter Kits are designed for urinary catheterization, providing a sterile and efficient means to manage urinary retention or incontinence. These kits include various components such as catheters and insertion tools, tailored for different patient needs. The hydrophilic and closed system options enhance ease of use and reduce the risk of infection.
Clinical Applications
These catheter kits are commonly used in urology, geriatrics, and rehabilitation settings. They are suitable for patients who require intermittent catheterization due to conditions like spinal cord injuries, multiple sclerosis, or post-surgical recovery. The closed system kits are particularly useful in reducing the risk of urinary tract infections in hospital or long-term care environments.
Indications for Use
The FDA-cleared indications for these catheter kits include managing urinary retention and incontinence. They are intended for patients who need assistance with bladder drainage due to neurological conditions or post-operative needs.
Practical Considerations
The kits come in various sizes to accommodate different patient anatomies, and the hydrophilic coating on some models facilitates smoother insertion. Clinicians should ensure compatibility with other urological equipment and follow sterile techniques to minimize infection risks.
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 Cure Catheter Kits used for?
They are used for urinary catheterization to manage urinary retention or incontinence.
What specialties typically use this device?
Urology, geriatrics, and rehabilitation medicine frequently use these catheter kits.
What are the FDA-cleared indications?
They are indicated for managing urinary retention and incontinence in patients needing bladder drainage assistance.
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.