Browse hierarchy: [Obstetrics/Gynecology (OB)](/submissions/OB) → [Subpart E — Obstetrical and Gynecological Surgical Devices](/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices) → [21 CFR 884.4270](/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/884.4270) → HHG — Dilator, Cervical, Vibratory

# HHG · Dilator, Cervical, Vibratory

_Obstetrics/Gynecology · 21 CFR 884.4270 · Class 3_

**Canonical URL:** https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/HHG

## Overview

- **Product Code:** HHG
- **Device Name:** Dilator, Cervical, Vibratory
- **Regulation:** [21 CFR 884.4270](/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/884.4270)
- **Device Class:** 3
- **Review Panel:** [Obstetrics/Gynecology](/submissions/OB)

## Identification

A vibratory cervical dilator is a device designed to dilate the cervical os by stretching it with a power-driven vibrating probe head. The device is used to gain access to the uterus or to induce abortion, but is not to be used during labor when a viable fetus is desired or anticipated.

## 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-e%E2%80%94obstetrical-and-gynecological-surgical-devices/HHG](https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/HHG)

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