{"data":{"id":"us/21-cfr-884.4160","jurisdiction":"us","citation":"21 CFR 884.4160","heading":"Unipolar endoscopic coagulator-cutter and accessories.","body":"(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.\n(b) Classification. Class II (performance standards).","path":["Title 21—Food and Drugs","CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES","SUBCHAPTER H—MEDICAL DEVICES","PART 884—OBSTETRICAL AND GYNECOLOGICAL DEVICES","Subpart E—Obstetrical and Gynecological Surgical Devices"],"source_url":"https://www.ecfr.gov/api/versioner/v1/full/2026-08-25/title-21.xml","current_through":"2026-08-25","vintage":"","retrieved_at":"2026-08-27T02:24:47Z","sha256":"61c1ee5afed073e29b8a04e93233161d3b38b13c606d6372427b27551259c513","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-884.4150","next":"us/21-cfr-884.4250"},"notice":"GroundRules: Original legal text. Not legal advice."}