Browse hierarchy: [Obstetrics/Gynecology (OB)](/submissions/OB) → [Subpart F — Obstetrical and Gynecological Therapeutic Devices](/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices) → [21 CFR 884.5050](/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/884.5050) → HHQ — System, Abortion, Metreurynter-Balloon

# HHQ · System, Abortion, Metreurynter-Balloon

_Obstetrics/Gynecology · 21 CFR 884.5050 · Class 3_

**Canonical URL:** https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/HHQ

## Overview

- **Product Code:** HHQ
- **Device Name:** System, Abortion, Metreurynter-Balloon
- **Regulation:** [21 CFR 884.5050](/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/884.5050)
- **Device Class:** 3
- **Review Panel:** [Obstetrics/Gynecology](/submissions/OB)

## 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).

## Recent Cleared Devices (0 of 0)

_No cleared devices on record._

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**Source:** [https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/HHQ](https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/HHQ)

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