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 ?
510(k)
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.
FDA-Cleared Indications
- Use in procedures involving the portal vein.
- Use when portal venous access or manipulation is required for a diagnostic or therapeutic intervention.
Clinical Applications
- Portal vein access during interventional procedures.
- Portal venous diagnostic procedures.
- Portal venous therapeutic procedures.
- Procedures involving the portal circulation in patients who require vascular access.
Practical Considerations
- Use only with compatible replaceable tips and accessory equipment specified by the manufacturer.
- Confirm the tip is securely attached before use and follow the manufacturer’s instructions for changing tips.
- The record does not specify tip sizes, dimensions, sterilization method, or single-use versus reusable status; verify these details in the current labeling.
- MRI safety is not established by the information provided. Confirm the device’s MR labeling before it enters the MRI environment.
- Patient- and procedure-specific contraindications depend on the planned portal venous intervention, vascular anatomy, bleeding risk, infection risk, and the device configuration.
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.