← Product Code [HDB](/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/HDB) · K934011

# MITYVAC(R) OBSTETRIC VAC DELIV KIT W/UNIV VAC RELEASE (K934011)

_Neward Enterprises, Inc. · HDB · May 4, 1994 · Obstetrics/Gynecology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/HDB/K934011

## Device Facts

- **Applicant:** Neward Enterprises, Inc.
- **Product Code:** [HDB](/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/HDB.md)
- **Decision Date:** May 4, 1994
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 884.4340
- **Device Class:** Class 2
- **Review Panel:** Obstetrics/Gynecology

## Regulatory 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.

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**Source:** [https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/HDB/K934011](https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/HDB/K934011)

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