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

Clearance details

Applicant

Atos Medical AB

Product code

Code EWL

Device class

Class 2

Regulation

21 CFR 874.3730

Advisory panel

Ear, Nose, Throat

Date received

2009-08-24

Decision date

2010-10-14

Decision

Unknown

Clearance type

Traditional

Location

Horby, SE

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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 →