part_subject: "OBSTETRICAL AND GYNECOLOGICAL DEVICES"
subpart_code: "E"
subpart_subject: "Obstetrical and Gynecological Surgical Devices"
section_number: "884.4160"
section_subject: "Unipolar endoscopic coagulator-cutter and accessories."
cfr_reference: "21 CFR 884.4160"
title_name: "Title 21"
title_subject: "Food and Drugs"
parts_covered: "Parts 800 to 1299"
revised_date: "Revised as of April 1, 2019"
publication_date: "As of April 1, 2019"
contains_description: "Containing a codification of documents of general applicability and future effect"
publication_info: "Published by the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register"
---
(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).