FLEXI-FLATE PENILE IMPLANT— 510(k) K834347

Substantially Equivalent

Surgitek

FDA 510(k) clearance K834347 for FLEXI-FLATE PENILE IMPLANT, Substantially Equivalent on 1984-04-02. Applicant: Surgitek.

Clearance details

Applicant: Surgitek
Product code: Code FAE
Advisory panel: Gastroenterology, Urology
Date received: 1983-12-13
Decision date: 1984-04-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, 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.