(170 days)
The Vesalius Essential device and its accessories are intended for resection, ablation and coagulation of soft tissues and haemostasis of blood vessels in surgical procedures in orthopedic, arthroscopic, neurosurgery, ENT, and spinal procedures.
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I am sorry, but the provided document does not contain the information required to answer your request. The document is an FDA 510(k) clearance letter for the "Vesalius" electrosurgical device, detailing its regulation, classification, and indications for use. It does not include acceptance criteria, performance data, details of specific studies, sample sizes, or ground truth establishment methods for device performance.
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.