21 CFR 876.3350 — Device, Impotence, Mechanical/Hydraulic
Gastroenterology, Urology (GU) · Subpart D—Prosthetic Devices · § 876.3350
Identification
A penile inflatable implant is a device that consists of two inflatable cylinders implanted in the penis, connected to a reservoir filled with radiopaque fluid implanted in the abdomen, and a subcutaneous manual pump implanted in the scrotum. When the cylinders are inflated, they provide rigidity to the penis. This device is used in the treatment of erectile impotence.
Classification Rationale
Class III (premarket approval).
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| FHW | Device, Impotence, Mechanical/Hydraulic | 3 | 1 | Implant |
| JCW | Prosthesis, Penis, Inflatable | 3 | 1 | Implant |
