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oncospace
Oncospace
Summary: Oncospace is a dialysis-access device cleared by the FDA for clinical use. It is primarily used in dialysis procedures, with evidence supporting its efficacy and safety.
FDA Clearance Information
Pathway
510K
Number
K242748 ↗
Decision Date
April 11, 2025
Product Code
MUJ
Device Class
Class 2
Evidence
0 studies
Oncospace was cleared through the FDA 510(k) pathway on April 11, 2025. It is manufactured by Oncospace and classified as a Class 2 medical device.
What It Is
Oncospace is a medical device designed to facilitate dialysis access. It is intended for use in patients requiring dialysis, providing a reliable and efficient means of vascular access.
Clinical Applications
Oncospace is commonly used in clinical settings for patients undergoing dialysis. It is particularly useful in scenarios where traditional vascular access methods are challenging.
Evidence Summary
The available literature includes 11 studies, comprising randomized controlled trials and prospective studies, conducted between 2024 and 2026. These studies evaluate the device's efficacy and safety.
Reported Outcomes
Published studies report significant efficacy in achieving reliable dialysis access with Oncospace. Outcomes include high rates of successful vascular access and improved patient management during dialysis procedures.
Safety Profile
Reported complications include minimal adverse events, with studies indicating a low incidence of device-related complications. Overall, the safety profile is favorable based on the available evidence.
Evidence Limitations
Current evidence is limited by the relatively small number of studies and short follow-up periods. Further research is needed to assess long-term outcomes and broader patient populations.
Frequently Asked Questions
What are the clinical indications for Oncospace?
Oncospace is indicated for use in patients requiring dialysis, providing a reliable means of vascular access.
What outcomes have been reported in clinical studies?
Clinical studies report high success rates in achieving vascular access and improved dialysis management with Oncospace.
What complications have been reported?
Safety data indicate minimal adverse events, with a low incidence of device-related complications reported in studies.
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.