{"data":{"id":"us/21-cfr-884.4150","jurisdiction":"us","citation":"21 CFR 884.4150","heading":"Bipolar endoscopic coagulator-cutter and accessories.","body":"(a) Identification. A bipolar endoscopic coagulator-cutter is a device used to perform female sterilization and other operative procedures under endoscopic observation. It destroys tissue with high temperatures by directing a high frequency electrical current through tissue between two electrical contacts of a probe. This generic type of device may include the following accessories: an electrical generator, probes, and electrical cables.\n(b) Classification. Class II. The special controls for this device are:\n(1) FDA's:\n(i) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ”\n(ii) “510(k) Sterility Review Guidance 2/12/90 (K-90),” and\n(iii) “Guidance (‘Guidelines’) for Evaluation of Laproscopic Bipolar and Thermal Coagulators (and Accessories),”\n(2) International Electrotechnical Commission's IEC 60601-1-AM2 (1995-03), Amendment 2, “Medical Electrical Equipment—Part 1: General Requirements for Safety,”\n(3) American National Standards Institute/American Association for Medical Instrumentation's HF-18, 1993, “Electrosurgical Devices,”\n(4) Labeling:\n(i) Indication: For female tubal sterilization, and\n(ii) Instructions for use:\n(A) Destroy at least 2 centimeters of the fallopian tubes,\n(B) Use a cut or undampened sinusoidal waveform,\n(C) Use a minimum power of 25 watts, and\n(D) For devices with ammeters: continue electrode activation for 5 seconds after the visual endpoint (tissue blanching) is reached or current flow ceases indicating adequate tissue destruction.","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":"548dd45594b450b9b825d7fe17b2afd46a006fc88cba064104f9d4a6ae2154c5","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-884.4120","next":"us/21-cfr-884.4160"},"notice":"GroundRules: Original legal text. Not legal advice."}