eCFR Reference Browser

---

title: "21 CFR §884.1300"

source: "https://www.ecfr.gov/current/title-21/section-884.1300"

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: "B"

subpart_subject: "Obstetrical and Gynecological Diagnostic Devices"

section_number: "884.1300"

section_subject: "Uterotubal carbon dioxide insufflator and accessories."

cfr_reference: "21 CFR 884.1300"

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 uterotubal carbon dioxide insufflator and accessories is a device used to test the patency (lack of obstruction) of the fallopian tubes by pressurizing the uterus and fallopian tubes and filling them with carbon dioxide gas.

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

§884.1300 - Uterotubal carbon dioxide insufflator and accessories.