FDA Product Code
FDA Product Code FAE — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Gastroenterology, Urology
- 21 CFR Citation
- 876.3630
510(k) Clearances — 32 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| 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 | Traditional | PDF ↗ |
| K181673 | Rigi10 Malleable Penile Prosthesis | Rigicon, Inc. | 2019-04-15 | Abbreviated | PDF ↗ |
| K090663 | AMS SPECTRA CONCEALABLE PENILE PROSTHESIS | American Medical Systems, Inc. | 2009-04-09 | Special | PDF ↗ |
| K082006 | AMS SPECTRA CONCEALABLE PENILE PROSTHESIS | American Medical Systems, Inc. | 2008-10-20 | Traditional | PDF ↗ |
| K040959 | MENTOR GENESIS PENILE PROSTHESIS | Mentor Corp. | 2004-10-29 | Traditional | PDF ↗ |
| K963328 | AMS AMBICOR PENILE PROSTHESIS | American Medical Systems, Inc. | 1996-12-04 | Traditional | PDF ↗ |
| K953640 | DUNA II PENILE PROSTHESIS | Dacomed Corp. | 1995-10-27 | Traditional | PDF ↗ |
| K951716 | AMS 650 MALLERABLE PENIEL PROSTHESIS | American Medical Systems, Inc. | 1995-07-06 | Traditional | PDF ↗ |
| K920420 | DURA II PENILE PROSTHESIS | Dacomed Corp. | 1992-04-16 | Traditional | PDF ↗ |
| K912935 | AMS MALLEABLE 600 AND 600M PENILE PROSTHESIS | American Medical Systems, Inc. | 1992-03-18 | Traditional | PDF ↗ |
| K912344 | MODIFIED DURAPHASE(TM) IMPLANTED PENILE PROSTHESIS | Dacomed Corp. | 1991-10-11 | Traditional | PDF ↗ |
| K910214 | AMS 700 ULTREX(TM) PRECONNECTED PENILE PROSTHESIS | American Medical Corp. | 1991-04-25 | Traditional | PDF ↗ |
| K904262 | MINNOW PENILE IMPLANT PROTECTOR | Ruja-Med Medical Marketing | 1990-12-13 | Traditional | PDF ↗ |
| K900371 | MENTOR MODIFIED MALLEABLE PENILE PROSTHESES | Mentor Corp. | 1990-11-02 | Traditional | PDF ↗ |
| K901482 | 700 ULTREX PENILE PROSTHESIS 12MM DIAMETER | American Medical Systems, Inc. | 1990-06-27 | Traditional | PDF ↗ |
| K896941 | AMS DYNAFLEX SELF CONTAINED PENILE PROSTHESIS | American Medical Systems, Inc. | 1990-03-06 | Traditional | PDF ↗ |
| K890402 | MENTOR CYLINDER PROTECTOR TOOL (INFLATABLE PENILE) | Mentor Corp. | 1989-08-03 | Traditional | PDF ↗ |
| K871653 | DURAPHASE PENILE PROSTHESIS | Dacomed Corp. | 1987-09-18 | Traditional | PDF ↗ |
| K864040 | BARD ESKA JONAS SILICONE-SILVER PENILE PROSTHESIS | C.R. Bard, Inc. | 1986-10-24 | Traditional | PDF ↗ |
| K860517 | MENTOR CORPORAL DILATORS | Mentor Corp. | 1986-03-11 | Traditional | PDF ↗ |
| K850019 | OMNI PHASE PENILE PROSTHESIS | Dacomed Corp. | 1985-04-09 | Traditional | PDF ↗ |
| K843280 | MALLEABLE PENILE PROSTHESIS | Mentor Corp. | 1984-10-24 | Traditional | PDF ↗ |
| K834347 | FLEXI-FLATE PENILE IMPLANT | Surgitek | 1984-04-02 | Traditional | PDF ↗ |
| K834504 | ESKA JONAS SILICON-SILVER PENILE | Dacomed Corp. | 1984-02-04 | Traditional | PDF ↗ |
| K832043 | SURGIKEK PENILE PROSTHESIS TAIL EXTEND | Medical Engineering Corp. | 1983-10-20 | Traditional | PDF ↗ |
| K831660 | AMS MALLEABLE PENILE PROSTHESIS | American Medical Systems, Inc. | 1983-08-08 | Traditional | PDF ↗ |
| K830917 | SURGITEK SIZER FOR PENILE PROSTHESIS | Medical Engineering Corp. | 1983-04-12 | Traditional | PDF ↗ |
| K830048 | INFLATABLE PENILE PROSTH. - CYLINDER | American Medical Systems, Inc. | 1983-04-12 | Traditional | PDF ↗ |
| K821628 | THE INFLATABLE PENILE PROSTHESIS | American Medical Systems, Inc. | 1982-08-10 | Traditional | PDF ↗ |
| K820081 | ESKA JONAS SILICONE-SILVER PENILE PROST | Dacomed Corp. | 1982-01-25 | Traditional | PDF ↗ |
| K803111 | ERECTAID | Burditt & Calkins-Siemens-Elema | 1981-01-23 | Traditional | PDF ↗ |
| K792724 | AMS MALLEABLE OR JONAS SILICONE-SILVER | American Medical Systems, Inc. | 1980-09-09 | Traditional | PDF ↗ |
Product code FAE · Class II · Gastroenterology, Urology. Data: openFDA.