PROVOX VEGA PUNCTURE SET— 510(k) K131947

Substantially Equivalent

Atos Medical AB

FDA 510(k) clearance K131947 for PROVOX VEGA PUNCTURE SET, Substantially Equivalent on 2013-10-18. Applicant: Atos Medical AB.

Clearance details

Applicant: Atos Medical AB
Product code: Code EWL
Advisory panel: Ear, Nose, Throat
Date received: 2013-06-27
Decision date: 2013-10-18
Decision: Substantially Equivalent
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.