AMS AMBICOR PENILE PROSTHESIS— 510(k) K963328

Substantially Equivalent

American Medical Systems, Inc.

FDA 510(k) clearance K963328 for AMS AMBICOR PENILE PROSTHESIS, Substantially Equivalent on 1996-12-04. Applicant: American Medical Systems, Inc..

Clearance details

Applicant: American Medical Systems, Inc.
Product code: Code FAE
Advisory panel: Gastroenterology, Urology
Date received: 1996-08-23
Decision date: 1996-12-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minnetonka, MN, US

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Adverse events under product code FAE

product code FAE

Injury: 995
Total: 995

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.