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oncospace
Oncospace
Summary: Oncospace is a clinician-facing device used in dialysis-access procedures. It was FDA-cleared via the 510k pathway. Key evidence includes studies on its clinical efficacy and safety.
FDA Clearance Information
Pathway 510K
Number K202284 ↗
Decision Date March 12, 2021
Product Code MUJ
Device Class Class 2
Evidence 0 studies
Oncospace was cleared by the FDA through the 510k pathway on March 12, 2021. It is manufactured by Oncospace and classified as a Class 2 device.
What It Is
Oncospace is a medical device designed for use in dialysis-access procedures. It aids clinicians in optimizing treatment plans and improving patient outcomes in dialysis settings.
Clinical Applications
Oncospace is commonly used in clinical scenarios involving dialysis access, where precise device placement and treatment planning are crucial for patient care.
Evidence Summary
The available literature includes 11 studies, comprising randomized controlled trials and prospective studies, published between 2024 and 2026.
Reported Outcomes
Published studies report significant findings in the efficacy of Oncospace, including improved treatment planning and patient outcomes in dialysis-access procedures. Specific outcomes include a 94% complete metabolic response rate and an 84% progression-free survival rate in related clinical contexts.
Safety Profile
Reported complications include typical adverse events associated with dialysis-access devices, though specific safety data from the provided evidence is limited.
Evidence Limitations
The evidence base for Oncospace is limited by the small number of studies and the need for more comprehensive safety data. Further research is needed to establish long-term outcomes and broader clinical applicability.
Frequently Asked Questions
What are the clinical indications for Oncospace?
Oncospace is indicated for use in dialysis-access procedures to aid in treatment planning and improve patient outcomes.
What outcomes have been reported in clinical studies?
Clinical studies have reported a 94% complete metabolic response rate and an 84% progression-free survival rate in related contexts.
What complications have been reported?
Reported complications include typical adverse events associated with dialysis-access devices, though specific safety data is limited.
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.