21 CFR 884.5050 — System, Abortion, Metreurynter-Balloon

Obstetrics/Gynecology (OB) · Part 884 Subpart F—Obstetrical and Gynecological Therapeutic Devices · § 884.5050

Identification

A metreurynter-balloon abortion system is a device used to induce abortion. The device is inserted into the uterine cavity, inflated, and slowly extracted. The extraction of the balloon from the uterus causes dilation of the cervical os. This generic type of device may include pressure sources and pressure controls.

Classification Rationale

Class III (premarket approval).

Product Codes

Product CodeDevice NameClassDevicesAttributes
HHQSystem, Abortion, Metreurynter-Balloon30
Innolitics

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