FAE — Prosthesis, Penile Class II
FDA Device Classification
Classification Details
- Product Code
- FAE
- Device Class
- Class II
- Regulation Number
- 876.3630
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- Yes
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K183619 | boston scientific corporation | Tactra Penile Prosthesis, 9.5 mm Device, Tactra Penile Prosthesis, 11 mm Device, | April 16, 2019 |
| K181673 | rigicon | Rigi10 Malleable Penile Prosthesis | April 15, 2019 |
| K090663 | american medical systems | AMS SPECTRA CONCEALABLE PENILE PROSTHESIS | April 9, 2009 |
| K082006 | american medical systems | AMS SPECTRA CONCEALABLE PENILE PROSTHESIS | October 20, 2008 |
| K040959 | mentor | MENTOR GENESIS PENILE PROSTHESIS | October 29, 2004 |
| K963328 | american medical systems | AMS AMBICOR PENILE PROSTHESIS | December 4, 1996 |
| K953640 | dacomed | DUNA II PENILE PROSTHESIS | October 27, 1995 |
| K951716 | american medical systems | AMS 650 MALLERABLE PENIEL PROSTHESIS | July 6, 1995 |
| K920420 | dacomed | DURA II PENILE PROSTHESIS | April 16, 1992 |
| K912935 | american medical systems | AMS MALLEABLE 600 AND 600M PENILE PROSTHESIS | March 18, 1992 |
| K912344 | dacomed | MODIFIED DURAPHASE(TM) IMPLANTED PENILE PROSTHESIS | October 11, 1991 |
| K910214 | american medical | AMS 700 ULTREX(TM) PRECONNECTED PENILE PROSTHESIS | April 25, 1991 |
| K904262 | ruja-med medical marketing | MINNOW PENILE IMPLANT PROTECTOR | December 13, 1990 |
| K900371 | mentor | MENTOR MODIFIED MALLEABLE PENILE PROSTHESES | November 2, 1990 |
| K901482 | american medical systems | 700 ULTREX PENILE PROSTHESIS 12MM DIAMETER | June 27, 1990 |
| K896941 | american medical systems | AMS DYNAFLEX SELF CONTAINED PENILE PROSTHESIS | March 6, 1990 |
| K890402 | mentor | MENTOR CYLINDER PROTECTOR TOOL (INFLATABLE PENILE) | August 3, 1989 |
| K871653 | dacomed | DURAPHASE PENILE PROSTHESIS | September 18, 1987 |
| K864040 | c.r. bard | BARD ESKA JONAS SILICONE-SILVER PENILE PROSTHESIS | October 24, 1986 |
| K860517 | mentor | MENTOR CORPORAL DILATORS | March 11, 1986 |