(72 days)
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Valley Forge Scientific Corp., the manufacturer of several Malis solid state bipolar coagulation/cutting systems, now plans to introduce a new Bipolar Loop Electrode which Dr. Malis has used to core all types of brain and spinal cord neoplasms such as meningiomas, neuromas, and gliomas bloodlessly. The loop electrodes restrict cutting current flow outside of the loops to any other tissues and no current to any ground. Accordingly, there is no heat spread.
I am sorry, but the provided text does not contain information about the acceptance criteria or a study that proves a device meets those criteria. The text describes the history and features of a bipolar electrosurgical coagulator and its accessories, but it does not present any specific performance metrics, study designs, or results that would allow me to fill in the requested table and information points.
§ 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.