';


Title 21 Part 884 → Subpart B → §884.1300

Title 21 → Chapter I → Subchapter H → Part 884 → Subpart B → §884.1300

Electronic Code of Federal Regulations e-CFR

Title 21 Part 884 → Subpart B → §884.1300

e-CFR data is current as of February 20, 2020

Title 21Chapter ISubchapter HPart 884Subpart B → §884.1300


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.

(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).