📋 FDA Reference
Unitips
Unisurge
Summary: The unitips is a Class 2 medical device used in procedures involving the portal vein. It is typically utilized by interventional radiologists and surgeons.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K930809 ↗
Decision Date ?
August 10, 1993
Product Code ?
GCJ
Device Class ?
Class 2
Evidence ?
0 studies
The unitips by Unisurge was cleared via the FDA 510k pathway on August 10, 1993. It is classified as a Class 2 device under product code GCJ.
What It Is
The unitips is a medical device designed for use in procedures involving the portal vein. It is typically used to facilitate access and intervention in the portal venous system. The device is engineered to be compatible with standard interventional techniques, providing reliable performance in complex vascular procedures.
FDA-Cleared Indications
- For use in procedures requiring access to the portal vein.
- For use in interventional procedures involving the portal venous system.
Clinical Applications
- Portal vein access during image-guided interventional procedures.
- Access to the portal venous system when performing a procedure involving portal venous intervention.
- Use by clinicians performing portal vein procedures in hospital-based interventional radiology or surgical settings.
Practical Considerations
- The FDA record supplied for this device does not specify the available sizes, lengths, materials, or compatible accessories; users should consult the current manufacturer labeling.
- Use requires knowledge of portal venous anatomy and image-guided vascular access techniques.
- The supplied FDA indication does not establish MRI safety. MRI compatibility should be verified in the current device labeling before scanning.
- Contraindications, access-route limitations, sterilization requirements, and handling instructions should be taken from the manufacturer’s instructions for use.
- The supplied record does not establish a fixed service life or duration of implantation; use should follow the labeled procedural instructions.
Frequently Asked Questions
What is unitips used for?
Unitips is used for accessing the portal vein in procedures like TIPS creation, particularly in patients with portal hypertension.
What specialties typically use this device?
Interventional radiologists and surgeons commonly use unitips in procedures involving the portal venous system.
What are the FDA-cleared indications?
Unitips is indicated for use in accessing the portal vein, particularly in patients with conditions requiring portal venous intervention.
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.