đź“‹ FDA Reference
hydrophilic-antibacterial intermittent catheter intermittent catheter closed system kit
Rochester Medical
Summary: The hydrophilic-antibacterial intermittent catheter by Rochester Medical is a device used for urinary catheterization, primarily in patients with urinary retention or neurogenic bladder. It is commonly used by urologists and healthcare providers in both hospital and outpatient settings.
FDA Clearance Information
Pathway
510K
Number
K033477 ↗
Decision Date
June 10, 2004
Product Code
MJC
Device Class
Class 2
Evidence
419 studies
This device was cleared through the FDA 510(k) pathway on June 10, 2004. It is manufactured by Rochester Medical and classified as a Class 2 device under product code MJC.
What It Is
The hydrophilic-antibacterial intermittent catheter is designed to facilitate urinary drainage in patients who require intermittent catheterization. It features a hydrophilic coating that becomes slippery when wet, reducing friction and discomfort during insertion and removal. The antibacterial properties help minimize the risk of urinary tract infections, a common complication associated with catheter use.
Clinical Applications
This catheter is commonly used in patients with conditions like spinal cord injuries, spina bifida, or multiple sclerosis, where neurogenic bladder is prevalent. It is typically employed in urology clinics, rehabilitation centers, and home care settings. The closed system kit version is particularly useful in reducing contamination risk during catheterization.
Indications for Use
The device is indicated for individuals who need intermittent urinary catheterization due to urinary retention or neurogenic bladder. It is suitable for both short-term and long-term use, depending on the patient's condition.
Practical Considerations
The catheter is available in various sizes to accommodate different patient anatomies. It is compatible with standard urinary drainage systems. Proper technique is essential to minimize infection risk, and the hydrophilic coating should be activated with sterile water before use.
Related Literature
The linked study compared the incidence of urinary tract infections in children with spina bifida using different types of catheters. Although the abstract is not available, the study likely focused on infection rates, comfort, and ease of use between catheter types. Limitations may include a small sample size or lack of long-term follow-up data.
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 hydrophilic-antibacterial intermittent catheter used for?
It is used for intermittent urinary catheterization to help drain the bladder in patients with urinary retention or neurogenic bladder.
What specialties typically use this device?
Urology, rehabilitation medicine, and home healthcare providers commonly use this device.
What are the FDA-cleared indications?
The device is indicated for intermittent catheterization in patients with urinary retention or neurogenic bladder conditions.
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.