PROVOX ACTIVALVE (SIZE 4.5MM, 6MM, 8MM, 10MM, 12.5MM)— 510(k) K092593

Unknown

Atos Medical AB

FDA 510(k) clearance K092593 for PROVOX ACTIVALVE (SIZE 4.5MM, 6MM, 8MM, 10MM, 12.5MM), Unknown on 2010-10-14. Applicant: Atos Medical AB.

Clearance details

Applicant: Atos Medical AB
Product code: Code EWL
Advisory panel: Ear, Nose, Throat
Date received: 2009-08-24
Decision date: 2010-10-14
Decision: Unknown
Clearance type: Traditional
Location: Horby, SE

Download summary PDF View on FDA.gov ↗

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.