Duna II Penile Prosthesis
FDA 510(k) K953640 · Dacomed Corp.
510(k) numberK953640
Submission
- Device name
- Duna II Penile Prosthesis
- Applicant
- Dacomed Corp.
Minneapolis, MN, US - Received
- August 4, 1995
- Decision date
- October 27, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FAE – Prosthesis, Penile
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.3630
- Specialty
- Gastroenterology, Urology
- Implant
- Yes
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| 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 |
| 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 |
More from Dacomed Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K941781 | Rigiscan Plus Rigidity Assessment SystemLIL · Traditional | 08/25/1994SE |
| K920409 | Dacomed Battery Operated Vacuum Erection DeviceLKY · Traditional | 05/11/1992SE |
| K920420 | Dura II Penile ProsthesisFAE · Traditional | 04/16/1992SE |
| K912344 | Modified Duraphase(Tm) Implanted Penile ProsthesisFAE · Traditional | 10/11/1991SE |
| K900774 | Dacomed Negative Pressure Erection DeviceLKY · Traditional | 05/04/1990SE |
| K885323 | Dacomed External Male Continence DeviceFHA · Traditional | 02/08/1989SE |
| K880391 | Dacomed CystometerEXQ · Traditional | 04/27/1988SE |
| K871653 | Duraphase Penile ProsthesisFAE · Traditional | 09/18/1987SE |
| K870320 | Dacomed Penile Prosthesis SizerJLW · Traditional | 03/17/1987SE |
| K854118 | Dacomed Corp. Eska-Herrman Voice ProsthesisEWL · Traditional | 03/17/1986SE |
Questions and answers
When was Duna II Penile Prosthesis cleared by the FDA?
Duna II Penile Prosthesis (K953640) received a 510(k) decision of Substantially Equivalent on October 27, 1995, 84 days after the submission was received.
What is the product code of K953640?
The FDA product code is FAE – Prosthesis, Penile, a Class II (moderate risk) device regulated under 21 CFR 876.3630.