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510(k) Data Aggregation
(218 days)
ARTHRO KINETICS VESALIUS MR GENERATOR, MODELS 2004-2006; ACCESSORIES FOR MR GENERATOR
Intended for resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in surgical procedures such as but not limited to orthopedic, arthroscopic, and spinal procedures.
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I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, or any studies conducted on the Arthro Kinetics Vesalius MR Generator. The document is a 510(k) premarket notification letter from the FDA, confirming that the device is substantially equivalent to legally marketed predicate devices. It discusses regulatory matters such as classification, general controls, and compliance, but it does not detail any technical performance criteria or study results.
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