700 ULTREX PENILE PROSTHESIS 12MM DIAMETER
Device Facts
| Record ID | K901482 |
|---|---|
| Device Name | 700 ULTREX PENILE PROSTHESIS 12MM DIAMETER |
| Applicant | American Medical Systems, Inc. |
| Product Code | FAE · Gastroenterology, Urology |
| Decision Date | Jun 27, 1990 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 876.3630 |
| Device Class | Class 2 |
Regulatory Classification
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.
Special Controls
The special control for this device is the FDA guidance entitled “Guidance for the Content of Premarket Notifications for Penile Rigidity Implants.”
