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The Stretta Control Module Model S400 RF electrosurgical generator with pump, in combination with CSM electrodes, is indicated for coagulation of tissue. This device is intended for use by qualified medical personnel, trained in the use of electrosurgery.

The Stretta Control Module Model S400 is an electrosurgical generator that is designed to deliver controlled low level radiofrequency energy for localized tissue coagulation. The Stretta generator has controls for maximum temperature, power delivered, energy delivered and time of energy delivered. The unit has readout for total energy delivered, impedance, maximum power and temperature for up to six channels. Connectors located on the front panel include electrode connectors and a foot pedal. A fluid pump is integrated into the Stretta generator to deliver cooling fluid to the surrounding tissue adjacent to the electrode.

System accessories include an AC power cord, a single-pedal footswitch and a connecting cable.

This document does not contain the requested information regarding acceptance criteria, device performance, or study details. It is a 510(k) premarket notification summary for a medical device (Stretta Control Module Model S400 RF Generator) and includes its intended use, description, comparison to a predicate device, and the FDA's clearance letter. It does not provide data from performance studies or specify acceptance criteria for such studies.

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