21 CFR 884.1300 — Insufflator, Carbon-Dioxide, Uterotubal (And Accessories)

Obstetrics/Gynecology (OB) · Part 884 Subpart B—Obstetrical and Gynecological Diagnostic Devices · § 884.1300

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.

Classification Rationale

Class II (performance standards).

Product Codes

Product CodeDevice NameClassDevicesAttributes
HESInsufflator, Carbon-Dioxide, Uterotubal (And Accessories)2133rd Party
Innolitics

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