21 C.F.R. § 884.1300 Uterotubal carbon dioxide insufflator and accessories.
Title 21 - Food and Drugs
(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).
Title 21: Food and Drugs
PART 884—OBSTETRICAL AND GYNECOLOGICAL DEVICES
Subpart B—Obstetrical and Gynecological Diagnostic Devices
§ 884.1300 Uterotubal carbon dioxide insufflator and accessories.