FTQ — Prosthesis, Penis, Rigid Rod Class II

FDA Device Classification

FDA product code FTQ covers "Prosthesis, Penis, Rigid Rod", a Class II medical device regulated under 21 CFR 876.3630. Submissions are reviewed by the Gastroenterology, Urology panel. Devices under this code are implants. At least 2 recent 510(k) clearances have been granted under this product code.