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These electrosurgical devices are designed for cutting of soft tissue and coagulation.

The unimed Coated Laparoscopic Electrode, unimed Coated Arthroscopy Electrode and the unimed Coated Suction-Irrigation Electrode are coated with Emralon 333 or Teflon 420-104. Both are dry lubricants which provide a low coefficient of friction and reduce eschar build-up during surgery and the need for higher power settings. Without eschar build-up that takes place with a standard stainless steel tip less scraping and inconvenience takes place resulting in greater OR efficiency. Each coating is non-toxic, corrosion resistant, and therefore safe for the patient and the OR staff. These electrosurgical devices are designed for cutting of soft tissue and coagulation. The electrodes are available in a variety of diameters, lengths and tip configurations. The electrodes are available sterile, single use only.

This abstract document is a medical device summary for an electrosurgical electrode and does not contain information about acceptance criteria or a study proving device performance in the context of AI/ML or diagnostic accuracy. The text describes the device, its materials, classification, and claims of substantial equivalence based on prior 510(k) notifications.

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