← Product Code [NBV](/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/NBV) · DEN000006

# EROS-CLITORAL THERAPY DEVICE (CTD) (DEN000006)

_Urometrics, Inc. · NBV · Apr 28, 2000 · Obstetrics/Gynecology · DENG_

**Canonical URL:** https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/NBV/DEN000006

## Device Facts

- **Applicant:** Urometrics, Inc.
- **Product Code:** [NBV](/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/NBV.md)
- **Decision Date:** Apr 28, 2000
- **Decision:** DENG
- **Submission Type:** Post-NSE
- **Regulation:** 21 CFR 884.5970
- **Device Class:** Class 2
- **Review Panel:** Obstetrics/Gynecology

## Regulatory Identification

A clitoral engorgement device is designed to apply a vacuum to the clitoris. It is intended for use in the treatment of female sexual arousal disorder.

## Special Controls

*Classification.* Class II (special controls). The special control is a guidance document entitled: “Guidance for Industry and FDA Reviewers: Class II Special Controls Guidance Document for Clitoral Engorgement Devices.”

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**Source:** [https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/NBV/DEN000006](https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/NBV/DEN000006)

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