đź“Š Evidence-Based Reference
Male Nelaton-Tip Ready-To-Use Hydrophilic Catheter Femal Nelaton-Tip Ready-To-Use Hydrophilic Catheter Pediatric Nelaton-Tip Ready-To-Use Hydrophilic Catheter Intermittent Catheter Male Tapered-Tip Tiemann Ready-To-Use Hydrophilic Catheter Male Olive-Tip Tiemann Ready-To-Use Hydrophilic Catheter
Hangzhou Bever Medical Devices
Summary: Hydrophilic catheters by Hangzhou Bever Medical Devices are used for intermittent catheterization. Key evidence highlights ease of use and high clinician agreement.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K192468 ↗
Decision Date ?
November 27, 2019
Product Code ?
GBM
Device Class ?
Class 2
Evidence ?
419 studies
The hydrophilic catheters were cleared through the FDA 510(k) pathway on November 27, 2019. Manufactured by Hangzhou Bever Medical Devices, they are classified as Class 2 medical devices.
What It Is
These are ready-to-use hydrophilic catheters designed for intermittent catheterization. They feature a hydrophilic coating that facilitates smooth insertion and removal, reducing friction and discomfort for patients.
FDA-Cleared Indications
- Intermittent catheterization to drain urine from the bladder.
- Use in male, female, and pediatric patients who require intermittent urinary catheterization.
Clinical Applications
- Intermittent bladder drainage when a patient cannot empty the bladder normally.
- Urethral catheterization in male patients using a Nelaton, tapered Tiemann, or olive-tip catheter.
- Urethral catheterization in female patients using a female Nelaton-tip catheter.
- Intermittent catheterization in pediatric patients using a pediatric Nelaton-tip catheter.
Evidence Summary
The literature includes three studies, with a focus on product evaluation and user satisfaction. The studies span from 2015 to 2020 and include randomized controlled trials and retrospective analyses.
Reported Outcomes
Published studies report high clinician agreement (90%) on the ease of use and learning of these catheters. Patient feedback indicates an 89% rate of easy or very easy catheter insertion, with 80% finding the learning curve manageable.
Safety Profile
Reported complications include urinary tract infections, a common issue with intermittent catheterization. However, specific safety data from the provided studies is limited.
Evidence Limitations
The evidence is limited by the small number of studies and lack of detailed safety outcomes. Further research is needed to compare these catheters with other designs and to explore long-term safety and efficacy.
Practical Considerations
- Choose the catheter length, French size, and tip configuration based on the patient's anatomy, age, clinical needs, and clinician instructions.
- The hydrophilic coating is intended to reduce friction during insertion and removal; follow the product instructions for activating or handling the ready-to-use catheter.
- These are intermittent catheters, not indwelling Foley catheters, and are generally removed after bladder drainage unless the treating clinician gives different instructions.
- Do not use if the package is damaged, the catheter is visibly contaminated, or the device has expired. Patients with urethral injury, significant obstruction, or active infection should be evaluated by a clinician before catheterization.
- The catheter is not an implanted device. MRI safety should be confirmed in the current manufacturer labeling because compatibility can depend on the specific materials and configuration.
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 hydrophilic catheters?
Hydrophilic catheters are indicated for intermittent catheterization in patients with incomplete bladder emptying.
What outcomes have been reported in clinical studies?
Studies report high clinician agreement on ease of use and a positive patient learning curve, with 89% finding insertion easy or very easy.
What complications have been reported?
Reported complications include urinary tract infections, a common issue with intermittent catheterization.
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.