đź“‹ FDA Reference

gore r dryseal sheath with hydrophilic coating

W.L. Gore & Associates

Summary: The GORE R DrySeal Sheath with hydrophilic coating is a medical device used primarily in vascular procedures to facilitate the introduction of interventional devices. It is commonly used by interventional radiologists and vascular surgeons.

FDA Clearance Information

Pathway 510K
Decision Date November 20, 2012
Product Code DYB
Device Class Class 2
Evidence 419 studies

The GORE R DrySeal Sheath was cleared through the FDA 510(k) pathway on November 20, 2012. It is manufactured by W.L. Gore & Associates and classified as a Class 2 device under product code DYB.

What It Is

The GORE R DrySeal Sheath is a vascular access device designed to provide a stable and secure entry point for interventional devices during endovascular procedures. Its hydrophilic coating reduces friction, allowing for smoother insertion and removal. This sheath is particularly useful in procedures requiring repeated access or the introduction of large devices.

Clinical Applications

This device is commonly used in endovascular procedures such as embolization, where precise delivery of coils or liquid agents is required. Interventional radiologists and vascular surgeons often use it in hospital settings, especially for patients requiring treatment of vascular abnormalities or aneurysms. Its design helps minimize trauma to the vessel wall, making it suitable for a wide range of patients.

Indications for Use

The GORE R DrySeal Sheath is indicated for use in procedures involving embolization, where it aids in the delivery of coils and liquid agents to treat vascular conditions. It is suitable for patients needing minimally invasive vascular interventions.

Practical Considerations

The sheath is available in various sizes to accommodate different patient anatomies and procedural requirements. Its hydrophilic coating necessitates proper hydration before use to ensure optimal performance. Clinicians should be familiar with the device's compatibility with other interventional tools.

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

Editorial - Philippe Ascher (1936-2022).

Neuroscience

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 GORE R DrySeal Sheath used for?

It is used to facilitate the introduction of interventional devices during vascular procedures, particularly in embolization.

What specialties typically use this device?

Interventional radiologists and vascular surgeons commonly use this device.

What are the FDA-cleared indications?

It is indicated for use in embolization procedures, assisting in the delivery of coils and liquid agents for vascular treatment.

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.

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