FTO — Prosthesis, Testicle Class III

FDA Device Classification

FDA product code FTO covers "Prosthesis, Testicle", a Class III medical device regulated under 21 CFR 876.3750. Submissions are reviewed by the Gastroenterology, Urology panel. Devices under this code are implants.

Classification Details

Product Code
FTO
Device Class
Class III
Regulation Number
876.3750
Submission Type
Review Panel
GU
Medical Specialty
Gastroenterology, Urology
Implant
Yes

Definition

Call for PMAs on 7/5/95 per 60 FR 17216 on 4/5/95