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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
510K
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.
Clinical Applications
These devices are commonly used in procedures involving the portal vein, such as interventions requiring precise vascular access or manipulation. They are integral in settings where detailed vascular work is necessary.
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.
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.