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gentlecath air for men hydrophilic intermittent urinary catheter
Convatec
Summary: The gentlecath air for men is a hydrophilic intermittent urinary catheter used for bladder management in men with urinary retention or neurogenic bladder. It is typically used by urologists or patients themselves under guidance.
FDA Clearance Information
Pathway
510K
Number
K213283 ↗
Decision Date
June 22, 2022
Product Code
GBM
Device Class
Class 2
Evidence
419 studies
The gentlecath air for men, manufactured by Convatec, received FDA clearance through the 510k pathway on June 22, 2022. It is classified as a Class 2 medical device under product code GBM.
What It Is
The gentlecath air for men is a hydrophilic intermittent urinary catheter designed for men who need assistance with bladder drainage. The catheter is coated with a hydrophilic layer that becomes slippery when activated by water, reducing friction and discomfort during insertion and removal. This device is particularly useful for patients with conditions such as spinal cord injuries or multiple sclerosis that affect bladder control.
Clinical Applications
This catheter is commonly used in urology and rehabilitation medicine for patients who require intermittent catheterization to manage urinary retention. It is suitable for use in both hospital and home settings, providing a convenient option for patients who perform self-catheterization. The device is particularly beneficial for male patients with neurogenic bladder due to spinal cord injury or other neurological conditions.
Indications for Use
The FDA-cleared indications for this device include use in male patients who need intermittent catheterization to manage urinary retention or neurogenic bladder. It is designed to facilitate bladder drainage in patients who cannot void naturally.
Practical Considerations
The gentlecath air for men is available in various sizes to accommodate different patient anatomies. It is important to ensure proper technique during insertion to minimize the risk of urinary tract infections. The hydrophilic coating requires activation with water, so clinicians should ensure that patients understand this step for effective use.
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 gentlecath air for men used for?
It is used for intermittent catheterization to manage urinary retention or neurogenic bladder in male patients.
What specialties typically use this device?
Urologists and rehabilitation specialists commonly use this device, and it is also used by patients themselves under medical guidance.
What are the FDA-cleared indications?
The device is indicated for male patients who require intermittent catheterization to manage urinary retention or neurogenic bladder.
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.