21 C.F.R. § 884.4160 Unipolar endoscopic coagulator-cutter and accessories.
Title 21 - Food and Drugs
(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).
Title 21: Food and Drugs
PART 884—OBSTETRICAL AND GYNECOLOGICAL DEVICES
Subpart E—Obstetrical and Gynecological Surgical Devices
§ 884.4160 Unipolar endoscopic coagulator-cutter and accessories.
