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Siterite Needle Guide Modified
Dymax
Summary: The Siterite Needle Guide Modified by Dymax is a medical device used to assist in the accurate placement of needles during procedures. It is commonly used by clinicians in settings requiring precise needle guidance, such as vascular access or biopsy procedures.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K931403 ↗
Decision Date ?
July 27, 1993
Product Code ?
DQY Catheter, Percutaneous
Device Class ?
Class 2
Evidence ?
0 studies
The Siterite Needle Guide Modified was cleared through the FDA 510k pathway on July 27, 1993. Manufactured by Dymax, it is classified as a Class 2 device under product code DQY.
What It Is
The Siterite Needle Guide Modified is a device designed to aid in the accurate placement of needles during medical procedures. It works by providing a stable and precise guide for the needle, reducing the risk of misplacement. This device is particularly useful in procedures where precision is critical, such as in the placement of venous stents or during biopsies.
FDA-Cleared Indications
- Used as a percutaneous catheter or needle-guidance device during procedures requiring accurate percutaneous access.
- Intended to assist clinicians with positioning a needle or catheter under imaging guidance.
- The available FDA record does not provide a more specific anatomical or procedural indication beyond the product classification and summary.
Clinical Applications
- Image-guided percutaneous vascular access.
- Needle guidance during venous interventions when percutaneous access is required.
- Percutaneous access associated with procedures involving central or iliac venous treatment.
- Guidance of a needle or catheter during other labeled percutaneous procedures, according to the device instructions for use.
Practical Considerations
- Use the guide with compatible needles, catheters, and imaging equipment specified by the manufacturer.
- Proper alignment, stabilization, and visualization are important to reduce needle deflection or unintended advancement.
- The available FDA record does not specify a universal needle-size range; confirm dimensions and compatibility in the device labeling.
- MRI safety is not established from the supplied FDA record. Confirm MR Safe, MR Conditional, or MR Unsafe status before entering an MRI environment.
- Contraindications, sterility, reuse, and handling requirements should be taken from the current manufacturer labeling and the clinical procedure protocol.
Procedures that use this device
Frequently Asked Questions
What is the Siterite Needle Guide Modified used for?
It is used to assist in the precise placement of needles during medical procedures, such as vascular access or biopsies.
What specialties typically use this device?
Specialties such as interventional radiology, vascular surgery, and oncology commonly use this device.
What are the FDA-cleared indications?
The device is indicated for use in procedures requiring accurate needle placement, particularly in venous interventions.
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.