Product code FAE
- Device name
- Prosthesis, Penile
- Medical specialty
- Gastroenterology, Urology
- Device class
- 2
- Regulation number
- 876.3630
- Review panel
- GU
- Implant
- Y
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K183619 | Tactra Penile Prosthesis, 9.5 mm Device, Tactra Penile Prosthesis, 11 mm Device, Tactra Penile Prosthesis, 13 mm Device | Boston Scientific Corporation | 2019-04-16 |
| K181673 | Rigi10 Malleable Penile Prosthesis | Rigicon, Inc. | 2019-04-15 |
| K090663 | AMS SPECTRA CONCEALABLE PENILE PROSTHESIS | American Medical Systems, Inc. | 2009-04-09 |
| K082006 | AMS SPECTRA CONCEALABLE PENILE PROSTHESIS | American Medical Systems, Inc. | 2008-10-20 |
| K040959 | MENTOR GENESIS PENILE PROSTHESIS | Mentor Corp. | 2004-10-29 |
| K963328 | AMS AMBICOR PENILE PROSTHESIS | American Medical Systems, Inc. | 1996-12-04 |
| K953640 | DUNA II PENILE PROSTHESIS | Dacomed Corp. | 1995-10-27 |
| K951716 | AMS 650 MALLERABLE PENIEL PROSTHESIS | American Medical Systems, Inc. | 1995-07-06 |
| K920420 | DURA II PENILE PROSTHESIS | Dacomed Corp. | 1992-04-16 |
| K912935 | AMS MALLEABLE 600 AND 600M PENILE PROSTHESIS | American Medical Systems, Inc. | 1992-03-18 |
| K912344 | MODIFIED DURAPHASE(TM) IMPLANTED PENILE PROSTHESIS | Dacomed Corp. | 1991-10-11 |
| K910214 | AMS 700 ULTREX(TM) PRECONNECTED PENILE PROSTHESIS | American Medical Corp. | 1991-04-25 |
| K904262 | MINNOW PENILE IMPLANT PROTECTOR | Ruja-Med Medical Marketing | 1990-12-13 |
| K900371 | MENTOR MODIFIED MALLEABLE PENILE PROSTHESES | Mentor Corp. | 1990-11-02 |
| K901482 | 700 ULTREX PENILE PROSTHESIS 12MM DIAMETER | American Medical Systems, Inc. | 1990-06-27 |
| K896941 | AMS DYNAFLEX SELF CONTAINED PENILE PROSTHESIS | American Medical Systems, Inc. | 1990-03-06 |
| K890402 | MENTOR CYLINDER PROTECTOR TOOL (INFLATABLE PENILE) | Mentor Corp. | 1989-08-03 |
| K871653 | DURAPHASE PENILE PROSTHESIS | Dacomed Corp. | 1987-09-18 |
| K864040 | BARD ESKA JONAS SILICONE-SILVER PENILE PROSTHESIS | C.R. Bard, Inc. | 1986-10-24 |
| K860517 | MENTOR CORPORAL DILATORS | Mentor Corp. | 1986-03-11 |
| K850019 | OMNI PHASE PENILE PROSTHESIS | Dacomed Corp. | 1985-04-09 |
| K843280 | MALLEABLE PENILE PROSTHESIS | Mentor Corp. | 1984-10-24 |
| K834347 | FLEXI-FLATE PENILE IMPLANT | Surgitek | 1984-04-02 |
| K834504 | ESKA JONAS SILICON-SILVER PENILE | Dacomed Corp. | 1984-02-04 |
| K832043 | SURGIKEK PENILE PROSTHESIS TAIL EXTEND | Medical Engineering Corp. | 1983-10-20 |
| K831660 | AMS MALLEABLE PENILE PROSTHESIS | American Medical Systems, Inc. | 1983-08-08 |
| K830048 | INFLATABLE PENILE PROSTH. - CYLINDER | American Medical Systems, Inc. | 1983-04-12 |
| K830917 | SURGITEK SIZER FOR PENILE PROSTHESIS | Medical Engineering Corp. | 1983-04-12 |
| K821628 | THE INFLATABLE PENILE PROSTHESIS | American Medical Systems, Inc. | 1982-08-10 |
| K820081 | ESKA JONAS SILICONE-SILVER PENILE PROST | Dacomed Corp. | 1982-01-25 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00850299008481 | RIGI10 | Rigicon, Inc. | 2024-01-26 |
| 00850299008443 | RIGI10 | Rigicon, Inc. | 2024-01-26 |
| 00850299008450 | RIGI10 | Rigicon, Inc. | 2024-01-26 |
| 00850299008467 | RIGI10 | Rigicon, Inc. | 2024-01-26 |
| 00850299008474 | RIGI10 | Rigicon, Inc. | 2024-01-26 |
| 00850299008047 | RIGI10™ | Rigicon, Inc. | 2019-12-12 |
| 00850299008030 | RIGI10™ | Rigicon, Inc. | 2019-12-12 |
| 00850299008023 | RIGI10™ | Rigicon, Inc. | 2019-12-12 |
| 00850299008016 | RIGI10™ | Rigicon, Inc. | 2019-12-12 |
| 00850299008009 | RIGI10™ | Rigicon, Inc. | 2019-12-12 |
| 08714729979357 | TACTRA | BOSTON SCIENTIFIC CORPORATION | 2019-05-06 |
| 08714729979340 | TACTRA | BOSTON SCIENTIFIC CORPORATION | 2019-05-06 |
| 08714729979364 | TACTRA | BOSTON SCIENTIFIC CORPORATION | 2019-05-06 |
| 00878953000497 | Sizer | AMERICAN MEDICAL SYSTEMS, INC. | 2016-09-24 |
| 00878953000503 | Sizer | AMERICAN MEDICAL SYSTEMS, INC. | 2016-09-24 |
| 00878953005201 | Spectra | AMERICAN MEDICAL SYSTEMS, INC. | 2016-08-12 |
| 00878953005218 | Spectra | AMERICAN MEDICAL SYSTEMS, INC. | 2016-08-12 |
| 00878953005225 | Spectra | AMERICAN MEDICAL SYSTEMS, INC. | 2016-08-12 |
| 00878953004044 | Rear Tip Extender | BOSTON SCIENTIFIC CORPORATION | 2016-08-12 |
| 00878953005232 | Spectra | AMERICAN MEDICAL SYSTEMS, INC. | 2016-08-12 |
| 00878953004112 | Rear Tip Extender | BOSTON SCIENTIFIC CORPORATION | 2016-08-12 |
| 00878953004105 | Rear Tip Extender | BOSTON SCIENTIFIC CORPORATION | 2016-08-12 |
| 00878953004099 | Rear Tip Extender | BOSTON SCIENTIFIC CORPORATION | 2016-08-12 |
| 00878953004082 | Rear Tip Extender | BOSTON SCIENTIFIC CORPORATION | 2016-08-12 |
| 00878953004075 | Rear Tip Extender | BOSTON SCIENTIFIC CORPORATION | 2016-08-12 |
| 00878953004068 | Rear Tip Extender | BOSTON SCIENTIFIC CORPORATION | 2016-08-12 |
| 00878953004051 | Rear Tip Extender | BOSTON SCIENTIFIC CORPORATION | 2016-08-12 |
| 05708932324687 | Genesis | Coloplast A/S | 2015-10-28 |
| 05708932324748 | Genesis | Coloplast A/S | 2015-10-28 |
| 05708932324809 | Genesis | Coloplast A/S | 2015-10-28 |