Prosthesis, Penile
FDA product code FAE · Class II (moderate risk) · 21 CFR 876.3630 · Gastroenterology, Urology
32510(k) clearances
0PMA approvals
3recalls
Implantimplanted device
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K183619 | Tactra Penile Prosthesis, 9.5 mm Device, Tactra Penile Prosthesis, 11 mm Device, Tactra…FAE · Traditional | Boston Scientific Corporation | 04/16/2019SE |
| K181673 | Rigi10 Malleable Penile ProsthesisFAE · Abbreviated | Rigicon, Inc. | 04/15/2019SE |
| K090663 | Ams Spectra Concealable Penile ProsthesisFAE · Special | American Medical Systems, Inc. | 04/09/2009SE |
| K082006 | Ams Spectra Concealable Penile ProsthesisFAE · Traditional | American Medical Systems, Inc. | 10/20/2008SE |
| K040959 | Mentor Genesis Penile ProsthesisFAE · Traditional | Mentor Corp. | 10/29/2004SE |
| K963328 | Ams Ambicor Penile ProsthesisFAE · Traditional | American Medical Systems, Inc. | 12/04/1996SE |
| K953640 | Duna II Penile ProsthesisFAE · Traditional | Dacomed Corp. | 10/27/1995SE |
| K951716 | Ams 650 Mallerable Peniel ProsthesisFAE · Traditional | American Medical Systems, Inc. | 07/06/1995SE |
| K920420 | Dura II Penile ProsthesisFAE · Traditional | Dacomed Corp. | 04/16/1992SE |
| K912935 | Ams Malleable 600 and 600M Penile ProsthesisFAE · Traditional | American Medical Systems, Inc. | 03/18/1992SE |
| K912344 | Modified Duraphase(Tm) Implanted Penile ProsthesisFAE · Traditional | Dacomed Corp. | 10/11/1991SE |
| K910214 | Ams 700 Ultrex(Tm) Preconnected Penile ProsthesisFAE · Traditional | American Medical Corp. | 04/25/1991SE |
| K904262 | Minnow Penile Implant ProtectorFAE · Traditional | Ruja-Med Medical Marketing | 12/13/1990SE |
| K900371 | Mentor Modified Malleable Penile ProsthesesFAE · Traditional | Mentor Corp. | 11/02/1990SE |
| K901482 | 700 Ultrex Penile Prosthesis 12MM DiameterFAE · Traditional | American Medical Systems, Inc. | 06/27/1990SE |
| K896941 | Ams Dynaflex Self Contained Penile ProsthesisFAE · Traditional | American Medical Systems, Inc. | 03/06/1990SE |
| K890402 | Mentor Cylinder Protector Tool (Inflatable Penile)FAE · Traditional | Mentor Corp. | 08/03/1989SE |
| K871653 | Duraphase Penile ProsthesisFAE · Traditional | Dacomed Corp. | 09/18/1987SE |
| K864040 | Bard Eska Jonas Silicone-Silver Penile ProsthesisFAE · Traditional | C.R. Bard, Inc. | 10/24/1986SE |
| K860517 | Mentor Corporal DilatorsFAE · Traditional | Mentor Corp. | 03/11/1986SE |
| K850019 | Omni Phase Penile ProsthesisFAE · Traditional | Dacomed Corp. | 04/09/1985SE |
| K843280 | Malleable Penile ProsthesisFAE · Traditional | Mentor Corp. | 10/24/1984SE |
| K834347 | Flexi-Flate Penile ImplantFAE · Traditional | Surgitek | 04/02/1984SE |
| K834504 | Eska Jonas Silicon-Silver PenileFAE · Traditional | Dacomed Corp. | 02/04/1984SE |
| K832043 | Surgikek Penile Prosthesis Tail ExtendFAE · Traditional | Medical Engineering Corp. | 10/20/1983SE |
| K831660 | Ams Malleable Penile ProsthesisFAE · Traditional | American Medical Systems, Inc. | 08/08/1983SE |
| K830917 | Surgitek Sizer for Penile ProsthesisFAE · Traditional | Medical Engineering Corp. | 04/12/1983SE |
| K830048 | Inflatable Penile Prosth. - CylinderFAE · Traditional | American Medical Systems, Inc. | 04/12/1983SE |
| K821628 | The Inflatable Penile ProsthesisFAE · Traditional | American Medical Systems, Inc. | 08/10/1982SE |
| K820081 | Eska Jonas Silicone-Silver Penile ProstFAE · Traditional | Dacomed Corp. | 01/25/1982SE |
| K803111 | ErectaidFAE · Traditional | Burditt & Calkins-Siemens-Elema | 01/23/1981SE |
| K792724 | Ams Malleable or Jonas Silicone-SilverFAE · Traditional | American Medical Systems, Inc. | 09/09/1980SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1538-2015 Class II | Genesis Malleable Penile Prosthesis, 9.5 mm, Catalog /Item Number 91-9509SC/519250.…Several lots of the 9.5 mm Genesis Malleable Penile Prosthesis were mislabeled. The Retail Box and Patient… | Coloplast Manufacturing US, LLC | 04/09/2015Terminated |
| Z-0703-2007 | AMS DURA-II Universal Tips, 2cm, Product Number 72009361, Sterile, American Medical…Mis-Labeling:The Dura-II 2 cm Universal Tips and the Dura-II 4 cm Distal Tips were incorrectly labeled with… | American Medical Systems | 02/19/2007Terminated |
| Z-0702-2007 | AMS DURA-II Distal Tips, 4 cm, Product Number 72009340, Sterile, American Medical…Mis-labeling: The Dura-II 2 cm Universal Tips and the Dura-II 4 cm Distal Tips were incorrectly labeled with… | American Medical Systems | 02/19/2007Terminated |