FAE · Prosthesis, Penile
Gastroenterology, Urology · 21 CFR 876.3630 · Class 2
Overview
| Product Code | FAE |
|---|---|
| Device Name | Prosthesis, Penile |
| 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 (20 of 32)
Showing 20 most recent of 32 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K183619 | Tactra Penile Prosthesis, 9.5 mm Device, Tactra Penile Prosthesis, 11 mm Device, Tactra Penile Prosthesis, 13 mm Device | Boston Scientific Corporation | Apr 16, 2019 | SESE |
| K181673 | Rigi10 Malleable Penile Prosthesis | Rigicon, Inc. | Apr 15, 2019 | SESE |
| K090663 | AMS SPECTRA CONCEALABLE PENILE PROSTHESIS | American Medical Systems, Inc. | Apr 9, 2009 | SESE |
| K082006 | AMS SPECTRA CONCEALABLE PENILE PROSTHESIS | American Medical Systems, Inc. | Oct 20, 2008 | SESE |
| K040959 | MENTOR GENESIS PENILE PROSTHESIS | Mentor Corp. | Oct 29, 2004 | SESE |
| K963328 | AMS AMBICOR PENILE PROSTHESIS | American Medical Systems, Inc. | Dec 4, 1996 | SESE |
| K953640 | DUNA II PENILE PROSTHESIS | Dacomed Corp. | Oct 27, 1995 | SESE |
| K951716 | AMS 650 MALLERABLE PENIEL PROSTHESIS | American Medical Systems, Inc. | Jul 6, 1995 | SESE |
| K920420 | DURA II PENILE PROSTHESIS | Dacomed Corp. | Apr 16, 1992 | SESE |
| K912935 | AMS MALLEABLE 600 AND 600M PENILE PROSTHESIS | American Medical Systems, Inc. | Mar 18, 1992 | SESE |
| K912344 | MODIFIED DURAPHASE(TM) IMPLANTED PENILE PROSTHESIS | Dacomed Corp. | Oct 11, 1991 | SESE |
| K910214 | AMS 700 ULTREX(TM) PRECONNECTED PENILE PROSTHESIS | American Medical Corp. | Apr 25, 1991 | SESE |
| K904262 | MINNOW PENILE IMPLANT PROTECTOR | Ruja-Med Medical Marketing | Dec 13, 1990 | SESE |
| K900371 | MENTOR MODIFIED MALLEABLE PENILE PROSTHESES | Mentor Corp. | Nov 2, 1990 | SESE |
| K901482 | 700 ULTREX PENILE PROSTHESIS 12MM DIAMETER | American Medical Systems, Inc. | Jun 27, 1990 | SESE |
| K896941 | AMS DYNAFLEX SELF CONTAINED PENILE PROSTHESIS | American Medical Systems, Inc. | Mar 6, 1990 | SESE |
| K890402 | MENTOR CYLINDER PROTECTOR TOOL (INFLATABLE PENILE) | Mentor Corp. | Aug 3, 1989 | SESE |
| K871653 | DURAPHASE PENILE PROSTHESIS | Dacomed Corp. | Sep 18, 1987 | SESE |
| K864040 | BARD ESKA JONAS SILICONE-SILVER PENILE PROSTHESIS | C.R. Bard, Inc. | Oct 24, 1986 | SESE |
| K860517 | MENTOR CORPORAL DILATORS | Mentor Corp. | Mar 11, 1986 | SESE |
Top Applicants
- American Medical Systems, Inc. — 11 clearances
- Dacomed Corp. — 7 clearances
- Mentor Corp. — 5 clearances
- Medical Engineering Corp. — 2 clearances
- Surgitek — 1 clearance
