LMA FAMILY OF AIRWAYS— 510(k) K130304

Substantially Equivalent

The Laryngeal Mask Co., Ltd.

FDA 510(k) clearance K130304 for LMA FAMILY OF AIRWAYS, Substantially Equivalent on 2014-05-30. Applicant: The Laryngeal Mask Co., Ltd..

Clearance details

Applicant: The Laryngeal Mask Co., Ltd.
Product code: Code CAE
Advisory panel: Anesthesiology
Date received: 2013-02-07
Decision date: 2014-05-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Research Triangle Park, NC, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code CAE

product code CAE

Death: 4
Total: 4

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.