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Rusch Flocath Hydrophilic Intermittent Catheter Rusch Mmg Hydrophilic Intermittent Catheter
Teleflexmedical
Summary: The Rusch Flocath Hydrophilic Intermittent Catheter is designed for intermittent catheterization to manage urinary retention. It is used by patients requiring bladder drainage, often due to neurological conditions or post-surgical needs.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K183461 ↗
Decision Date ?
May 8, 2019
Product Code ?
GBM
Device Class ?
Class 2
Evidence ?
419 studies
The Rusch Flocath Hydrophilic Intermittent Catheter was cleared via the FDA 510k pathway on May 8, 2019. It is manufactured by Teleflexmedical and is classified as a Class 2 medical device.
What It Is
The Rusch Flocath Hydrophilic Intermittent Catheter is a medical device used for intermittent catheterization to facilitate bladder drainage. It features a hydrophilic coating that becomes slippery when activated by water, reducing friction and discomfort during insertion and removal. This design aims to improve patient comfort and reduce the risk of urethral trauma.
FDA-Cleared Indications
- Intermittent catheterization for bladder drainage in patients with urinary retention or incomplete bladder emptying.
- Use through the urethra to access and drain the urinary bladder.
Clinical Applications
- Intermittent urethral catheterization for urinary retention.
- Bladder drainage when normal urination is temporarily or chronically impaired.
- Intermittent catheterization in hospital, rehabilitation, or home-care settings when prescribed and taught by a healthcare professional.
Practical Considerations
- The hydrophilic coating must be activated according to the product instructions, typically with water, before insertion.
- Catheters are available in different French sizes and lengths; the appropriate size should be selected by a clinician based on patient anatomy and drainage needs.
- Use requires training in hand hygiene, catheter insertion, urine drainage, removal, and disposal. Follow the manufacturer’s instructions and local infection-control guidance.
- This is generally a single-use device and should not be reused unless the specific labeling permits it.
- The FDA record does not establish MRI safety; review the current labeling or contact the manufacturer before use in or near an MRI environment. Contraindications and precautions should be checked in the package insert.
Related Literature
The linked study from 2005 examined the Flocath Quick, a hydrophilic-coated catheter for intermittent use. It highlighted the device's potential to enhance the quality of life for users and caregivers by reducing discomfort and ease of use. However, the study was limited by its early stage and lack of extensive clinical trials, suggesting a need for further research to validate these findings.
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 Hydrophilic Intermittent Catheter used for?
It is used for intermittent catheterization to manage urinary retention in patients with conditions affecting bladder function.
What specialties typically use this device?
Urology, neurology, and rehabilitation specialists commonly use this device, as well as healthcare providers in surgical and home care settings.
What are the FDA-cleared indications?
The catheter is indicated for patients requiring intermittent catheterization due to urinary retention, often related to neurological conditions 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.