FAF · Prosthesis, Testicular
Gastroenterology, Urology · 21 CFR 876.3750 · Class 3
Overview
| Product Code | FAF |
|---|---|
| Device Name | Prosthesis, Testicular |
| 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 (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| P020003 | COLOPLAST SALINE-FILLED TESTICULAR PROSTHESIS | Coloplast Corp. | Jul 19, 2002 | APPR |
Top Applicants
- Coloplast Corp. — 1 clearance
