📋 FDA Reference
Sos Bloodless Needle
E-Z-Em
Summary: The SOS Bloodless Needle is a medical device used for procedures requiring embolization coils. It is primarily utilized by interventional radiologists and vascular surgeons.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K914330 ↗
Decision Date ?
December 20, 1991
Product Code ?
DYB
Device Class ?
Class 2
Evidence ?
0 studies
The SOS Bloodless Needle was cleared through the FDA 510(k) pathway on December 20, 1991. Manufactured by E-Z-Em, it is classified as a Class 2 device under product code DYB.
What It Is
The SOS Bloodless Needle is a specialized medical device designed to facilitate the placement of embolization coils in blood vessels. It minimizes blood loss during procedures by providing a controlled and precise method of coil delivery. This device is particularly useful in interventional radiology for managing vascular abnormalities.
FDA-Cleared Indications
- Use in procedures requiring embolization coils.
- Use to facilitate the placement of embolization coils in blood vessels.
Clinical Applications
- Catheter-based embolization of abnormal blood vessels using embolization coils.
- Coil embolization to stop or reduce blood flow through a target vessel.
- Embolization of aneurysms or other vascular abnormalities when coil delivery is required.
Practical Considerations
- The appropriate needle size depends on the access technique, device configuration, and vessel or catheter dimensions.
- Compatibility with the selected embolization coils and other delivery equipment must be confirmed before use.
- The device should be handled by clinicians trained in vascular access, fluoroscopic guidance, and coil embolization.
- The record provided does not specify MRI safety labeling; MRI compatibility should be confirmed in the current manufacturer instructions before scanning.
- Contraindications, warnings, and limitations should be taken from the current device labeling. Patient-specific risks include bleeding, infection, vessel injury, non-target embolization, and complications related to vascular access.
Procedures that use this device
Frequently Asked Questions
What is the SOS Bloodless Needle used for?
It is used for delivering embolization coils to block blood flow in specific vascular procedures.
What specialties typically use this device?
Interventional radiologists and vascular surgeons commonly use this device.
What are the FDA-cleared indications?
The device is indicated for use in embolization procedures to manage vascular abnormalities.
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.