§ 884.4160. Unipolar endoscopic coagulator-cutter and accessories.
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/us/cfr/t21/s§ 884.4160·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(a)Identification. A unipolar endoscopic coagulator-cutter is a device designed to destroy tissue with high temperatures by directing a high frequency electrical current through the tissue between an energized probe and a grounding plate. It is used in female sterilization and in other operative procedures under endoscopic observation. This generic type of device may include the following accessories: an electrical generator, probes and electrical cables, and a patient grounding plate. This generic type of device does not include devices used to perform female sterilization under hysteroscopic observation.
(b)Classification. Class II (performance standards).