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§ 884.1300 Uterotubal carbon dioxide insufflator and accessories.

21 CFR 884.1300

Citation21 CFR 884.1300
CorpusDaily eCFR
Displayed edition2026-04-15
Last updated2026-04-15

§ 884.1300 Uterotubal carbon dioxide insufflator and accessories.

(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).