K912344

Substantially Equivalent

MODIFIED DURAPHASE(TM) IMPLANTED PENILE PROSTHESIS

Applicant: Dacomed Corp.
Product code: FAE
Advisory panel: Gastroenterology, Urology
Date received: 1991-05-28
Decision date: 1991-10-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minneapolis, MN, US

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.