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Nipro Hydrophilic Guidewire for Urological Laparoscopic Use
Summary: The Nipro Hydrophilic Guidewire is a medical device used in urological laparoscopic procedures. It is primarily utilized by urologists to facilitate the placement of catheters or other devices within the urinary tract.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K060034 ↗
Decision Date ?
February 28, 2006
Product Code ?
OCY
Device Class ?
Class 2
Evidence ?
419 studies
The Nipro Hydrophilic Guidewire was cleared through the FDA 510(k) pathway on February 28, 2006. It is manufactured by Nipro Medical and classified as a Class 2 device under product code OCY.
What It Is
The Nipro Hydrophilic Guidewire is a flexible, coated wire designed for use in urological procedures. Its hydrophilic coating allows it to glide smoothly through the urinary tract, minimizing trauma to delicate tissues. This guidewire is an essential tool for navigating complex anatomical pathways during laparoscopic surgeries.
FDA-Cleared Indications
- Facilitation of device placement within the urinary tract during urological laparoscopic procedures.
Clinical Applications
- Guiding compatible catheters through the urinary tract during laparoscopic urological procedures.
- Facilitating placement of other compatible urological devices within the urinary tract.
- Providing a pathway for device navigation when access to the ureter or kidney is required during an indicated laparoscopic procedure.
Practical Considerations
- Available length and diameter options should be selected for the anatomy, access route and compatible catheter or device.
- The hydrophilic coating generally requires wetting according to the product instructions before use; avoid allowing the coating to dry during the procedure.
- Advance and withdraw the wire under appropriate imaging or direct procedural guidance without force. Resistance may indicate obstruction, malposition or tissue injury.
- Compatibility with the intended catheter, scope or other device should be confirmed before use.
- MRI safety and conditional-use information must be verified in the current manufacturer labeling; do not assume that every guidewire configuration is MRI safe.
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 Nipro Hydrophilic Guidewire used for?
It is used to facilitate the placement of catheters and other devices within the urinary tract during urological procedures.
What specialties typically use this device?
Urologists primarily use this device in both hospital and outpatient surgical settings.
What are the FDA-cleared indications?
The guidewire is indicated for use in urological laparoscopic procedures to aid in the placement of devices within the urinary tract.
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.