AIRTRAQ SP AIRTRAQ AVANT— 510(k) K121378

Substantially Equivalent

Prodol Meditec , Ltd.

FDA 510(k) clearance K121378 for AIRTRAQ SP AIRTRAQ AVANT, Substantially Equivalent on 2012-06-21. Applicant: Prodol Meditec , Ltd..

Clearance details

Applicant: Prodol Meditec , Ltd.
Product code: Code CCW
Advisory panel: Anesthesiology
Date received: 2012-05-08
Decision date: 2012-06-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bonita Springs, FL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code CCW

product code CCW

Death: 31
Injury: 136
Malfunction: 3,703
Other: 1
Total: 3,871

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.