FHW · Device, Impotence, Mechanical/Hydraulic
Gastroenterology, Urology · 21 CFR 876.3350 · Class 3
Overview
| Product Code | FHW |
|---|---|
| Device Name | Device, Impotence, Mechanical/Hydraulic |
| Regulation | 21 CFR 876.3350 |
| Device Class | Class 3 |
| Review Panel | Gastroenterology, Urology |
| Implant | Yes |
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).
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| P000006 | TITAN INFLATABLE PENILE PROSTHESIS | Coloplast Corp. | Jul 14, 2000 | APPR |
Top Applicants
- Coloplast Corp. — 1 clearance
