21 CFR § 884.4120 - Gynecologic electrocautery and accessories.

---
identifier: "/us/cfr/t21/s884.4120"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 884.4120 - Gynecologic electrocautery and accessories."
title_number: 21
title_name: "Food and Drugs"
section_number: "884.4120"
section_name: "Gynecologic electrocautery 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"
---


# 884.4120 Gynecologic electrocautery and accessories.

(a) *Identification.* A gynecologic electrocautery is a device designed to destroy tissue with high temperatures by tissue contact with an electrically heated probe. It is used to excise cervical lesions, perform biopsies, or treat chronic cervicitis under direct visual observation. This generic type of device may include the following accessories: an electrical generator, a probe, and electrical cables.

(b) *Classification.* Class II (performance standards).