FAE
- Product code
- FAE
- Device name
- Prosthesis, Penile
- Device class
- Class 2
- 21 CFR
- 21 CFR 876.3630
- Medical specialty
- Gastroenterology, Urology
- Marketing pathway
- 510(K)
- Flag
- Implant
- 510(k) clearances (all years, FDA)
- 32 (all years; only the last 3 years are listed here)
Official FDA classification page: FAE
Classification and pathway per current FDA publications. Data from openFDA (CC0).