Broncoflex Agile +3 more— 510(k) K202180

Name: FDA 510(k) clearance K202180
Creator: U.S. Food and Drug Administration
Published: 2020-10-22

Substantially Equivalent

Axess Vision Technology

FDA 510(k) clearance K202180 for Broncoflex Agile +3 more, Substantially Equivalent on 2020-10-22. Applicant: Axess Vision Technology. Device class: 2.

Clearance details

Device name as filed: Broncoflex Agile; Product Reference: 20030001 , Broncoflex Vortex; Product Reference: 10030001, Screeni; Product Reference: 30030001
Applicant: Axess Vision Technology
Product code: Code EOQ
Device class: Class 2
Regulation: 21 CFR 874.4680
Advisory panel: Ear, Nose, Throat
Date received: 2020-08-04
Decision date: 2020-10-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Joué-Lès-Tours, FR

Download summary PDF View on FDA.gov ↗

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Adverse events under product code EOQ

product code EOQ

Death: 135
Injury: 2,863
Malfunction: 21,662
Total: 24,660

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.