OBY — Condom, Female, Animal Tissue Class III
FDA product code OBY covers "Condom, Female, Animal Tissue", a Class III medical device regulated under 21 CFR 884.5330. Submissions are reviewed by the Obstetrics/Gynecology panel.
Classification Details
- Product Code
- OBY
- Device Class
- Class III
- Regulation Number
- 884.5330
- Submission Type
- Review Panel
- OB
- Medical Specialty
- Obstetrics/Gynecology
- Implant
- No
Definition
A female condom is a sheath-like device that lines the vaginal wall and is inserted into the vagina prior to the initiation of coitus. It is indicated for contraceptive and prophylactic (preventing the transmission of sexually transmitted diseases) purposes.