AMS MALLEABLE PENILE PROSTHESIS— 510(k) K831660
Substantially EquivalentAmerican Medical Systems, Inc.
FDA 510(k) clearance K831660 for AMS MALLEABLE PENILE PROSTHESIS, Substantially Equivalent on 1983-08-08. Applicant: American Medical Systems, Inc..
Clearance details
- Applicant
- American Medical Systems, Inc.
- Product code
- Code FAE
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Walker, MI, US
Adverse events under product code FAE
product code FAE- Injury
- 995
- Total
- 995
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.