Ams Malleable Penile Prosthesis
FDA 510(k) K831660 · American Medical Systems, Inc.
510(k) numberK831660
Submission
- Device name
- Ams Malleable Penile Prosthesis
- Applicant
- American Medical Systems, Inc.
Walker, MI, US - Received
- May 23, 1983
- Decision date
- August 8, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
| 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 |
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| 510(k) | Device | Decision |
|---|---|---|
| K140679 | Sureflex Lithotripsy Laser FibersGEX · Traditional | 06/20/2014SE |
| K131229 | Sparc System and Monarc, Monarc, and Monarc C SystemsOTN · Special | 12/05/2013SE |
| K132655 | Retroarc Retropubic Sling SystemOTN · Traditional | 11/20/2013SE |
| K121805 | Ams Large Pore Polyprophlene MeshOTO · Traditional | 10/16/2012SE |
| K121641 | Miniarc Pro Single-Incision Sling SystemPAH · Traditional | 09/07/2012SE |
| K121612 | Elevate Prolapse Repair Systems-Apical Needle Passer Sheath ModificationOTP · Special | 07/20/2012SE |
| K120870 | Greenlight Moxy Fiber OpticGEX · Special | 06/15/2012SE |
| K112842 | Ams Elevate PCOTP · Special | 10/25/2011SE |
| K111118 | Ams Elevate PC Apical and Posterior ( and Anterior and Apical) Prolapse Repair System…OTP · Special | 07/01/2011SE |
| K100746 | Fiber OneGEX · Traditional | 06/11/2010SE |
Questions and answers
When was Ams Malleable Penile Prosthesis cleared by the FDA?
Ams Malleable Penile Prosthesis (K831660) received a 510(k) decision of Substantially Equivalent on August 8, 1983, 77 days after the submission was received.
What is the product code of K831660?
The FDA product code is FAE – Prosthesis, Penile, a Class II (moderate risk) device regulated under 21 CFR 876.3630.