đź“‹ FDA Reference
i a handpiece with replaceable tips
Surgical Technologies
Summary: The i a handpiece with replaceable tips is a medical device used primarily in procedures involving the portal vein. It is typically utilized by surgeons in vascular and interventional radiology settings.
FDA Clearance Information
Pathway 510K
Number K910245 ↗
Decision Date April 22, 1991
Product Code GBX
Device Class Class 1
Evidence 0 studies
The i a handpiece with replaceable tips was cleared through the FDA 510(k) pathway on April 22, 1991. Manufactured by Surgical Technologies, it is classified as a Class 1 device under product code GBX.
What It Is
The i a handpiece with replaceable tips is a surgical tool designed for use in procedures involving the portal vein. It features interchangeable tips to accommodate various procedural needs, enhancing its versatility. The device is designed to facilitate precise access and manipulation within the vascular system, making it a valuable tool in surgical and interventional settings.
Clinical Applications
This device is commonly used in vascular surgery and interventional radiology, particularly in procedures involving the portal vein. It is suitable for use in both hospital and outpatient settings, where precise vascular access is required. The device is often employed in treating conditions such as portal hypertension or in procedures requiring portal vein access.
Indications for Use
The FDA indications suggest that this device is intended for use in procedures involving the portal vein. It is suitable for patients requiring vascular access for diagnostic or therapeutic interventions involving the portal circulation.
Practical Considerations
The handpiece is compatible with a range of replaceable tips, allowing for flexibility in various procedures. Clinicians should ensure compatibility with existing equipment and be familiar with the technique for changing tips to optimize procedural efficiency.
Frequently Asked Questions
What is the i a handpiece with replaceable tips used for?
It is used for procedures involving the portal vein, facilitating precise vascular access and manipulation.
What specialties typically use this device?
Vascular surgeons and interventional radiologists commonly use this device.
What are the FDA-cleared indications?
The device is indicated for use in procedures involving the portal vein, such as those requiring vascular access for diagnostic or therapeutic purposes.
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.