21 CFR 876.3750 — Prosthesis, Testicular
Gastroenterology, Urology (GU) · Subpart D—Prosthetic Devices · § 876.3750
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).
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| FAF | Prosthesis, Testicular | 3 | 1 | Implant |
| FTO | Prosthesis, Testicle | 3 | 0 | Implant |
