OMNI PHASE PENILE PROSTHESIS— 510(k) K850019

Substantially Equivalent

Dacomed Corp.

FDA 510(k) clearance K850019 for OMNI PHASE PENILE PROSTHESIS, Substantially Equivalent on 1985-04-09. Applicant: Dacomed Corp..

Clearance details

Applicant: Dacomed Corp.
Product code: Code FAE
Advisory panel: Gastroenterology, Urology
Date received: 1985-01-03
Decision date: 1985-04-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minneapolis, 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.