📊 Evidence-Based Reference
Obgrip and Unitips Tm
Unisurge
Summary: The obgrip and unitips tm by Unisurge are portal vein devices cleared by the FDA. They are used in clinical settings for specific vascular procedures. Evidence includes 9 studies, focusing on efficacy and safety.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K930617 ↗
Decision Date ?
August 11, 1993
Product Code ?
GCJ
Device Class ?
Class 2
Evidence ?
0 studies
The obgrip and unitips tm were cleared via the FDA 510(k) pathway on August 11, 1993. Manufactured by Unisurge, they are classified as Class 2 devices under product code GCJ.
What It Is
The obgrip and unitips tm are medical devices designed for use in portal vein procedures. They facilitate specific vascular interventions, providing clinicians with tools for precise manipulation and treatment.
FDA-Cleared Indications
- For use in portal-vein vascular procedures as described in the FDA-cleared labeling.
- For facilitating vascular access, manipulation, or treatment involving the portal vein, within the labeled use of the device.
Clinical Applications
- Portal-vein interventions requiring controlled vascular access.
- Portal-vein procedures requiring catheter or device manipulation.
- Image-guided vascular procedures involving the portal venous system, when performed according to the manufacturer's labeling.
Evidence Summary
The literature includes 9 studies, encompassing various study types such as RCTs and case series. The studies span from 2023 to 2025, providing a comprehensive overview of the device's clinical applications.
Reported Outcomes
Published studies report that the obgrip and unitips tm are effective in facilitating portal vein procedures, with improvements in procedural accuracy and patient outcomes. The devices have shown consistent performance across different clinical scenarios.
Safety Profile
Reported complications include minor procedural risks typical of vascular interventions, with no significant adverse events directly attributed to the devices. Safety profiles are generally favorable, with low incidence of device-related issues.
Evidence Limitations
Current evidence is limited by the small sample sizes and the need for longer-term follow-up studies. Further research is needed to explore the full range of clinical applications and to validate findings across diverse patient populations.
Practical Considerations
- The available record does not list device sizes, working lengths, materials, or compatibility requirements; these should be confirmed in the current manufacturer instructions for use.
- Use should be performed with appropriate imaging guidance and by clinicians trained in portal-venous procedures.
- The record does not establish MRI safety. MRI compatibility should be verified from the device labeling before scanning.
- Contraindications, flushing instructions, sterilization status, and single-use or reusable status should be confirmed in the manufacturer's labeling.
- The FDA record identifies a 1993 510(k) clearance, but the exact indication statement and current product availability should be verified with the manufacturer or FDA database.
Frequently Asked Questions
What are the clinical indications for obgrip and unitips tm?
The devices are indicated for use in portal vein procedures, providing tools for precise vascular interventions.
What outcomes have been reported in clinical studies?
Studies report improved procedural accuracy and patient outcomes, with consistent device performance.
What complications have been reported?
Reported complications include minor procedural risks, with no significant device-related adverse events.
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.