Subpart D—Prosthetic Devices
FDA submissions for Subpart D—Prosthetic Devices in the Gastroenterology, Urology (GU) review panel, including product codes and regulations.
Section range: §§ 876.3350–876.3750
CFR Part: 876
Product Codes
| Product Code | Device Name | Regulation | Class | Devices |
|---|---|---|---|---|
| FHW | Device, Impotence, Mechanical/Hydraulic | 876.3350 | 3 | 1 |
| JCW | Prosthesis, Penis, Inflatable | 876.3350 | 3 | 1 |
| QGA | Penile Implant Surgical Accessories | 876.3500 | 1 | 0 |
| FAE | Prosthesis, Penile | 876.3630 | 2 | 32 |
| FTQ | Prosthesis, Penis, Rigid Rod | 876.3630 | 2 | 2 |
| FAF | Prosthesis, Testicular | 876.3750 | 3 | 1 |
| FTO | Prosthesis, Testicle | 876.3750 | 3 | 0 |
