FTQ · Prosthesis, Penis, Rigid Rod
Gastroenterology, Urology · 21 CFR 876.3630 · Class 2
Overview
| Product Code | FTQ |
|---|---|
| Device Name | Prosthesis, Penis, Rigid Rod |
| Regulation | 21 CFR 876.3630 |
| Device Class | Class 2 |
| Review Panel | Gastroenterology, Urology |
| Implant | Yes |
Identification
A penile rigidity implant is a device that consists of a pair of semi-rigid rods implanted in the corpora cavernosa of the penis to provide rigidity. It is intended to be used in men diagnosed as having erectile dysfunction.
Classification Rationale
Class II. The special control for this device is the FDA guidance entitled “Guidance for the Content of Premarket Notifications for Penile Rigidity Implants.”
Special Controls
The special control for this device is the FDA guidance entitled “Guidance for the Content of Premarket Notifications for Penile Rigidity Implants.”
Recent Cleared Devices (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K983015 | VIRILIS PENILE PROSTHESIS | Specialty Surgical Products, Inc. | Feb 5, 1999 | SESE |
| K830667 | SILICONE-SILVER PENILE PROSTHESIS-ESK | Dacomed Corp. | Oct 20, 1983 | SESE |
Top Applicants
- Dacomed Corp. — 1 clearance
- Specialty Surgical Products, Inc. — 1 clearance
