MITYVAC(R) OBSTETRIC VAC DELIV KIT W/UNIV VAC RELEASE
Device Facts
| Record ID | K934011 |
|---|---|
| Device Name | MITYVAC(R) OBSTETRIC VAC DELIV KIT W/UNIV VAC RELEASE |
| Applicant | Neward Enterprises, Inc. |
| Product Code | HDB · Obstetrics/Gynecology |
| Decision Date | May 4, 1994 |
| Decision | SESE |
| Submission Type | Traditional |
| 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.
