21 CFR § 884.4160 - Unipolar endoscopic coagulator-cutter and accessories.

---
identifier: "/us/cfr/t21/s884.4160"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 884.4160 - Unipolar endoscopic coagulator-cutter and accessories."
title_number: 21
title_name: "Food and Drugs"
section_number: "884.4160"
section_name: "Unipolar endoscopic coagulator-cutter and accessories."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "H"
subchapter_name: "MEDICAL DEVICES"
part_number: "884"
part_name: "OBSTETRICAL AND GYNECOLOGICAL DEVICES"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 351, 360, 360c, 360e, 360j, 360, 371."
regulatory_source: "45 FR 12684, Feb. 26, 1980, unless otherwise noted."
cfr_part: "884"
---


# 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).