SURGITEK SIZER FOR PENILE PROSTHESIS— 510(k) K830917

Substantially Equivalent

Medical Engineering Corp.

FDA 510(k) clearance K830917 for SURGITEK SIZER FOR PENILE PROSTHESIS, Substantially Equivalent on 1983-04-12. Applicant: Medical Engineering Corp..

Clearance details

Applicant: Medical Engineering Corp.
Product code: Code FAE
Advisory panel: Gastroenterology, Urology
Date received: 1983-03-22
Decision date: 1983-04-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, 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.