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co-axial introducer needle
Promex
Summary: The co-axial introducer needle by Promex is primarily used in procedures requiring precise needle placement, such as biopsies. Key evidence highlights its use in ultrasound-guided biopsies and post-mortem examinations.
FDA Clearance Information
Pathway
510K
Number
K022634 ↗
Decision Date
November 6, 2002
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The co-axial introducer needle by Promex was cleared by the FDA through the 510(k) pathway on November 6, 2002. It is classified as a Class 2 device under product code DYB.
What It Is
The co-axial introducer needle is a medical device designed to facilitate precise needle placement in clinical procedures. It is commonly used in conjunction with imaging techniques for biopsies and other diagnostic interventions.
Clinical Applications
This device is frequently employed in ultrasound-guided biopsies, particularly in urology and pediatric cases, as well as in post-mortem examinations for tissue sampling. Its design allows for accurate targeting and minimal patient discomfort.
Evidence Summary
The literature includes four studies, ranging from 2017 to 2025, covering various applications of the co-axial introducer needle. These studies include randomized controlled trials and methodological reviews.
Reported Outcomes
Published studies report the co-axial introducer needle's effectiveness in facilitating accurate biopsy procedures, particularly in prostate and pediatric cases. The device's use in post-mortem examinations has also been noted for its precision and efficiency.
Safety Profile
Reported complications include potential discomfort during transperineal prostate biopsies due to necessary transducer angulations. No significant adverse events were noted in the reviewed studies.
Evidence Limitations
The current evidence is limited by a lack of large-scale randomized controlled trials specifically focusing on the co-axial introducer needle. Further research is needed to explore long-term outcomes and safety in diverse clinical settings.
Frequently Asked Questions
What are the clinical indications for co-axial introducer needle?
The co-axial introducer needle is indicated for use in procedures requiring precise needle placement, such as ultrasound-guided biopsies and post-mortem tissue sampling.
What outcomes have been reported in clinical studies?
Studies report effective use in accurate biopsy procedures, particularly in prostate and pediatric cases, with noted precision in post-mortem examinations.
What complications have been reported?
Reported complications include potential discomfort during certain biopsy procedures, but no significant adverse events were documented in the available studies.
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.