OYO — Culture, Intravaginal, Assisted Reproduction Class II
FDA product code OYO covers "Culture, Intravaginal, Assisted Reproduction", a Class II medical device regulated under 21 CFR 884.6165. Submissions are reviewed by the Obstetrics/Gynecology panel. At least 2 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- OYO
- Device Class
- Class II
- Regulation Number
- 884.6165
- Submission Type
- 510(k)
- Review Panel
- OB
- Medical Specialty
- Obstetrics/Gynecology
- Implant
- No
Definition
Intravaginal culture of human gametes and embryos. To hold and maintain gametes and developing embryos over the duration of the intravaginal culture period.