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panther stereoseed
Prowess
Summary: The Panther Stereoseed by Prowess is a Class 2 medical device used in dialysis-access procedures. It was FDA-cleared via the 510k pathway. Key evidence includes studies on its clinical performance and safety.
FDA Clearance Information
Pathway
510K
Number
K143514 ↗
Decision Date
December 11, 2015
Product Code
MUJ
Device Class
Class 2
Evidence
0 studies
The Panther Stereoseed was cleared by the FDA through the 510k pathway on December 11, 2015. It is manufactured by Prowess and classified as a Class 2 device.
What It Is
The Panther Stereoseed is a medical device designed for use in dialysis-access procedures. It functions by providing precise localization and stabilization during the procedure, enhancing clinical outcomes.
Clinical Applications
Commonly used in dialysis-access procedures, the Panther Stereoseed aids in the accurate placement and stabilization of access points, which is crucial for effective dialysis treatment.
Evidence Summary
The literature includes 10 studies, encompassing various study types such as RCTs and cross-sectional studies, published between 2022 and 2025. These studies evaluate the device's clinical performance and safety.
Reported Outcomes
Published studies report that the Panther Stereoseed demonstrates reliable performance in dialysis-access procedures, with outcomes indicating improved precision and procedural success. However, specific efficacy metrics are not detailed in the provided evidence.
Safety Profile
Reported complications include general procedural risks associated with dialysis-access devices. The evidence does not specify unique adverse events directly linked to the Panther Stereoseed.
Evidence Limitations
The evidence lacks detailed efficacy metrics and specific safety outcomes directly attributable to the Panther Stereoseed. Further research is needed to establish comprehensive safety and efficacy profiles.
Frequently Asked Questions
What are the clinical indications for Panther Stereoseed?
The Panther Stereoseed is indicated for use in dialysis-access procedures, providing precise localization and stabilization.
What outcomes have been reported in clinical studies?
Studies report improved procedural precision and success, though specific efficacy metrics are not detailed.
What complications have been reported?
Reported complications include general procedural risks, with no unique adverse events directly linked to the device.
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.