HHG · Dilator, Cervical, Vibratory
Obstetrics/Gynecology · 21 CFR 884.4270 · Class 3
Overview
| Product Code | HHG |
|---|---|
| Device Name | Dilator, Cervical, Vibratory |
| Regulation | 21 CFR 884.4270 |
| Device Class | Class 3 |
| Review Panel | Obstetrics/Gynecology |
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.
