OHC · Obstetrical Vacuum Delivery Kit
Obstetrics/Gynecology · 21 CFR 884.4340 · Class 2
Overview
| Product Code | OHC |
|---|---|
| Device Name | Obstetrical Vacuum Delivery Kit |
| Regulation | 21 CFR 884.4340 |
| Device Class | Class 2 |
| Review Panel | Obstetrics/Gynecology |
Identification
A fetal vacuum extractor is a device used to facilitate delivery. The device enables traction to be applied to the fetal head (in the birth canal) by means of a suction cup attached to the scalp and is powered by an external vacuum source. This generic type of device may include the cup, hosing, vacuum source, and vacuum control.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (0 of 0)
No cleared devices on record.
