OBY · Condom, Female, Animal Tissue
Obstetrics/Gynecology · 21 CFR 884.5330 · Class 3
Overview
| Product Code | OBY |
|---|---|
| Device Name | Condom, Female, Animal Tissue |
| Regulation | 21 CFR 884.5330 |
| Device Class | Class 3 |
| Review Panel | Obstetrics/Gynecology |
Identification
A multiple-use female condom is a sheath-like device that lines the vaginal wall and is inserted into the vagina prior to the initiation of coitus. At the conclusion of coitus, the device can be reused. It is indicated for contraception and prophylactic (preventing the transmission of sexually transmitted infections) purposes.
Classification Rationale
Class III (premarket approval).
Recent Cleared Devices (0 of 0)
No cleared devices on record.
