Browse hierarchy: [Obstetrics/Gynecology (OB)](/submissions/OB) → [Subpart F — Obstetrical and Gynecological Therapeutic Devices](/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices) → [21 CFR 884.5970](/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/884.5970) → NBV — Device, Engorgement, Clitoral

# NBV · Device, Engorgement, Clitoral

_Obstetrics/Gynecology · 21 CFR 884.5970 · Class 2_

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

## Overview

- **Product Code:** NBV
- **Device Name:** Device, Engorgement, Clitoral
- **Regulation:** [21 CFR 884.5970](/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/884.5970)
- **Device Class:** 2
- **Review Panel:** [Obstetrics/Gynecology](/submissions/OB)

## 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.

## Classification Rationale

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.”

## 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.”

## Recent Cleared Devices (3 of 3)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K043480](https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/NBV/K043480.md) | ENHANCE CLITORAL STIMULATION AID | Gynavations, Inc. | Jun 8, 2005 | SESE |
| [K001576](https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/NBV/K001576.md) | EVA -VACUUM ASSIST DEVICE FOR CLITORAL THERAPY | Prosurg, Inc. | Dec 28, 2000 | SESE |
| [DEN000006](https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/NBV/DEN000006.md) | EROS-CLITORAL THERAPY DEVICE (CTD) | Urometrics, Inc. | Apr 28, 2000 | DENG |

## Top Applicants

- Gynavations, Inc. — 1 clearance
- Prosurg, Inc. — 1 clearance
- Urometrics, Inc. — 1 clearance

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

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