21 CFR 884.5970 — Device, Engorgement, Clitoral
Obstetrics/Gynecology (OB) · Part 884 Subpart F—Obstetrical and Gynecological Therapeutic Devices · § 884.5970
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.”
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| NBV | Device, Engorgement, Clitoral | 2 | 3 |
Special Controls
NBV — Device, Engorgement, Clitoral
*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.”
eCFR
NBV — Device, Engorgement, Clitoral
The special control is a guidance document entitled: “Guidance for Industry and FDA Reviewers: Class II Special Controls Guidance Document for Clitoral Engorgement Devices.”
Ecfr Llm
