MITYVAC
Device Facts
| Record ID | K011532 |
|---|---|
| Device Name | MITYVAC |
| Applicant | Prism Enterprises, Inc. |
| Product Code | HDB · Obstetrics/Gynecology |
| Decision Date | Jul 30, 2001 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 884.4340 |
| Device Class | Class 2 |
Regulatory Classification
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.
