📋 FDA Reference
Rusch Flocath Quick 18 Fr Coude Hydrophilic Intermittent Catheter
Teleflexmedical
Summary: The Rusch Flocath Quick 18 Fr Coude Hydrophilic Intermittent Catheter is used for urinary catheterization, primarily by urologists and healthcare providers in clinical settings.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K181979 ↗
Decision Date ?
May 24, 2019
Product Code ?
KOD
Device Class ?
Class 2
Evidence ?
419 studies
The Rusch Flocath Quick 18 Fr Coude Catheter was cleared via the FDA 510(k) pathway on May 24, 2019. It is manufactured by Teleflexmedical and classified as a Class 2 device.
What It Is
The Rusch Flocath Quick 18 Fr Coude Hydrophilic Intermittent Catheter is a medical device designed for intermittent urinary catheterization. It features a coude tip, which is angled to facilitate navigation through the urethra, especially in patients with an enlarged prostate or urethral stricture. The hydrophilic coating is activated by water, reducing friction during insertion and removal, enhancing patient comfort.
FDA-Cleared Indications
- Intermittent catheterization for bladder drainage in patients with urinary retention or inadequate bladder emptying.
- Use through the urethra to access and drain the urinary bladder.
- The coude tip is intended to facilitate urethral catheterization when the urethral anatomy makes passage of a straight-tip catheter difficult.
Clinical Applications
- Intermittent urethral catheterization for urinary retention.
- Bladder drainage in patients with neurogenic bladder or impaired bladder emptying.
- Catheterization when an angled tip is needed to navigate the urethra.
- Intermittent catheterization in hospital, outpatient, or home-care settings when prescribed and taught by a healthcare professional.
Practical Considerations
- This device is 18 French and is generally selected for adult intermittent catheterization when that size is clinically appropriate; catheter size should be chosen by a qualified clinician.
- The hydrophilic coating must be activated according to the product instructions, typically with sterile or clean water as specified by the labeling.
- The coude tip has a defined orientation and should be aligned according to the manufacturer's instructions before insertion.
- It is an intermittent catheter rather than an indwelling Foley catheter and is intended for single use unless the labeling specifically states otherwise.
- MRI safety depends on the exact materials and labeling for the packaged product. Confirm the current manufacturer instructions before use during an MRI examination; do not assume MRI compatibility from the catheter name alone.
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 Rusch Flocath Quick 18 Fr Coude Catheter used for?
It is used for intermittent urinary catheterization, particularly in patients with urinary retention or neurogenic bladder.
What specialties typically use this device?
Urologists, primary care physicians, and healthcare providers in rehabilitation and home care settings commonly use this device.
What are the FDA-cleared indications?
The device is indicated for bladder drainage in patients with urinary retention or neurogenic bladder, especially those with anatomical challenges.
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.