LibAirty Airway Clearance System— 510(k) K242063

Substantially Equivalent

Synchrony Medical , Ltd.

FDA 510(k) clearance K242063 for LibAirty Airway Clearance System, Substantially Equivalent on 2024-12-19. Applicant: Synchrony Medical , Ltd..

Clearance details

Applicant: Synchrony Medical , Ltd.
Product code: Code BYI
Advisory panel: Anesthesiology
Date received: 2024-07-15
Decision date: 2024-12-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Or Yehuda, IL

Download summary PDF View on FDA.gov ↗

Adverse events under product code BYI

product code BYI

Death: 3
Total: 3

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.