QYZ — At Home Intravaginal Insemination System Class II
FDA product code QYZ covers "At Home Intravaginal Insemination System", a Class II medical device regulated under 21 CFR 884.6110. Submissions are reviewed by the Obstetrics/Gynecology panel. At least 3 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- QYZ
- Device Class
- Class II
- Regulation Number
- 884.6110
- Submission Type
- Review Panel
- OB
- Medical Specialty
- Obstetrics/Gynecology
- Implant
- No
Definition
To deliver semen to the vaginal canal for insemination.