BIVONA ECONOMY DUCKBILL VOICE PROSTHESIS— 510(k) K861088

Substantially Equivalent

Bivona Medical Technologies

FDA 510(k) clearance K861088 for BIVONA ECONOMY DUCKBILL VOICE PROSTHESIS, Substantially Equivalent on 1986-04-02. Applicant: Bivona Medical Technologies.

Clearance details

Applicant: Bivona Medical Technologies
Product code: Code EWL
Advisory panel: Ear, Nose, Throat
Date received: 1986-03-21
Decision date: 1986-04-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gary, IN, US

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Adverse events under product code EWL

product code EWL

Death: 2
Total: 2

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.