FTO · Prosthesis, Testicle
Gastroenterology, Urology · 21 CFR 876.3750 · Class 3
Overview
| Product Code | FTO |
|---|---|
| Device Name | Prosthesis, Testicle |
| Regulation | 21 CFR 876.3750 |
| Device Class | Class 3 |
| Review Panel | Gastroenterology, Urology |
| Implant | Yes |
Identification
A testicular prosthesis is an implanted device that consists of a solid or gel-filled silicone rubber prosthesis that is implanted surgically to resemble a testicle.
Classification Rationale
Class III (premarket approval).
Recent Cleared Devices (0 of 0)
No cleared devices on record.
