21 C.F.R. § 884.4160

Current through May 31, 2024
Section 884.4160 - Unipolar endoscopic coagulator-cutter and accessories
(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).

21 C.F.R. §884.4160