FAE — Prosthesis, Penile Class II
FDA product code FAE covers "Prosthesis, Penile", a Class II medical device regulated under 21 CFR 876.3630. Submissions are reviewed by the Gastroenterology, Urology panel. Devices under this code are implants. At least 20 recent 510(k) clearances have been granted under this product code.
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 |