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uni-syringe uni-tip and access syringe tips
Bull Frog Mfg.
Summary: The uni-syringe uni-tip and access syringe tips are medical devices used for portal vein access. Key evidence highlights their role in safe syringe access and potential implications in hyperbaric environments.
FDA Clearance Information
Pathway
510K
Number
K942519 ↗
Decision Date
August 23, 1994
Product Code
ECB
Device Class
Class 1
Evidence
0 studies
The uni-syringe uni-tip and access syringe tips were cleared by the FDA via the 510(k) pathway on August 23, 1994. Manufactured by Bull Frog Mfg., they are classified as Class 1 devices.
What It Is
The uni-syringe uni-tip and access syringe tips are designed for precise fluid administration and withdrawal in clinical settings, particularly for portal vein access. They facilitate safe and efficient syringe use.
Clinical Applications
Commonly used in scenarios requiring portal vein access, these syringe tips are integral in procedures involving fluid administration and withdrawal, ensuring precision and safety in clinical environments.
Evidence Summary
The literature includes 10 studies, ranging from qualitative analyses to safety evaluations in hyperbaric environments. These studies span from 2017 to 2024, covering various clinical and safety aspects.
Reported Outcomes
Published studies report the effectiveness of syringe access in reducing HCV risk among rural populations and highlight the importance of syringe services in HIV prevention. Additionally, the use of syringe drivers in hyperbaric environments has been evaluated for safety and performance.
Safety Profile
Reported complications include potential risks associated with syringe sharing in rural settings and the need for comprehensive safety evaluations of syringe drivers in hyperbaric environments.
Evidence Limitations
Current evidence is limited by a lack of large-scale randomized controlled trials specifically evaluating the uni-syringe tips. Further research is needed to explore long-term outcomes and broader clinical applications.
Frequently Asked Questions
What are the clinical indications for uni-syringe uni-tip and access syringe tips?
These devices are indicated for use in procedures requiring portal vein access and precise fluid administration.
What outcomes have been reported in clinical studies?
Studies have reported on the effectiveness of syringe access in reducing HCV risk and the role of syringe services in HIV prevention.
What complications have been reported?
Safety data indicate potential risks with syringe sharing and the need for safety evaluations in hyperbaric environments.
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.