Ams Malleable 600 and 600M Penile Prosthesis
FDA 510(k) K912935 · American Medical Systems, Inc.
510(k) numberK912935
Submission
- Device name
- Ams Malleable 600 and 600M Penile Prosthesis
- Applicant
- American Medical Systems, Inc.
Minnetonka, MN, US - Received
- July 5, 1991
- Decision date
- March 18, 1992
- 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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|---|---|---|---|
| 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 |
| K912344 | Modified Duraphase(Tm) Implanted Penile ProsthesisFAE · Traditional | Dacomed Corp. | 10/11/1991SE |
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Questions and answers
When was Ams Malleable 600 and 600M Penile Prosthesis cleared by the FDA?
Ams Malleable 600 and 600M Penile Prosthesis (K912935) received a 510(k) decision of Substantially Equivalent on March 18, 1992, 257 days after the submission was received.
What is the product code of K912935?
The FDA product code is FAE – Prosthesis, Penile, a Class II (moderate risk) device regulated under 21 CFR 876.3630.