eCFR Reference Browser

---

title: "21 CFR §884.4120"

source: "https://www.ecfr.gov/current/title-21/section-884.4120"

title_number: "21"

volume_number: "8"

chapter_number: "Unknown"

subchapter_code: "H"

subchapter_subject: "MEDICAL DEVICES"

part_code: "884"

part_subject: "OBSTETRICAL AND GYNECOLOGICAL DEVICES"

subpart_code: "E"

subpart_subject: "Obstetrical and Gynecological Surgical Devices"

section_number: "884.4120"

section_subject: "Gynecologic electrocautery and accessories."

cfr_reference: "21 CFR 884.4120"

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 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).

§884.4120 - Gynecologic electrocautery and accessories.