← Product Code [HDB](/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/HDB) · K011532

# MITYVAC (K011532)

_Prism Enterprises, Inc. · HDB · Jul 30, 2001 · Obstetrics/Gynecology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/HDB/K011532

## Device Facts

- **Applicant:** Prism Enterprises, Inc.
- **Product Code:** [HDB](/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/HDB.md)
- **Decision Date:** Jul 30, 2001
- **Decision:** SESE
- **Submission Type:** Special
- **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/K011532](https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/HDB/K011532)

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