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hi-slip and hi-slip plus single use hydrophilic urinary catheters and kit
Oasis Medikal Urunler Kimya Sanayi Ve Tic A.S.
Summary: The hi-slip and hi-slip plus are single-use hydrophilic urinary catheters designed for intermittent catheterization. Cleared by the FDA via the 510(k) pathway, they are primarily used for patients requiring bladder drainage. Limited evidence is available on their specific clinical outcomes and safety.
FDA Clearance Information
Pathway
510K
Number
K062444 ↗
Decision Date
February 22, 2007
Product Code
EZD
Device Class
Class 2
Evidence
419 studies
The hi-slip and hi-slip plus catheters were cleared by the FDA through the 510(k) pathway on February 22, 2007. Manufactured by Oasis Medikal Urunler Kimya Sanayi Ve Tic A.S., these devices are classified as Class 2 under product code EZD.
What It Is
The hi-slip and hi-slip plus are hydrophilic urinary catheters intended for single-use in intermittent catheterization. They are designed to facilitate smooth insertion and removal, reducing friction and discomfort for patients.
Clinical Applications
These catheters are commonly used in clinical scenarios where patients require intermittent catheterization for bladder drainage, such as in cases of urinary retention or neurogenic bladder.
Evidence Summary
The available literature includes 10 studies, primarily randomized controlled trials, published between 2023 and 2025. However, none of the studies directly address the hi-slip catheters, indicating a gap in specific evidence.
Reported Outcomes
Published studies report limited direct evidence on the efficacy of hi-slip catheters. The studies provided do not specifically evaluate the outcomes related to these devices, highlighting a need for targeted research.
Safety Profile
Reported complications include a lack of specific safety data for hi-slip catheters in the provided studies. General catheter-related complications may include urinary tract infections and discomfort.
Evidence Limitations
The evidence lacks direct studies on hi-slip catheters, with no specific outcomes or safety data available. Further research is needed to evaluate their clinical efficacy and safety profile.
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 hi-slip catheters?
Hi-slip catheters are indicated for intermittent catheterization in patients requiring bladder drainage.
What outcomes have been reported in clinical studies?
There is a lack of specific outcomes reported for hi-slip catheters in the available studies.
What complications have been reported?
Safety data specific to hi-slip catheters is not available in the provided evidence. General catheter-related complications may occur.
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.