SHILEY NEONATAL TRACHEOSTOMY TUBE CUFFLESS, SHILEY PEDIATRIC TRACHEOSTOMY TUBE CUFFLESS, SHILEY PEDIATRIC TRACHEOSTOMY T— 510(k) K122531

Substantially Equivalent

Covidien

FDA 510(k) clearance K122531 for SHILEY NEONATAL TRACHEOSTOMY TUBE CUFFLESS, SHILEY PEDIATRIC TRACHEOSTOMY TUBE CUFFLESS, SHILEY PEDIATRIC TRACHEOSTOMY T, Substantially Equivalent on 2012-10-09. Applicant: Covidien.

Clearance details

Applicant: Covidien
Product code: Code JOH
Advisory panel: Anesthesiology
Date received: 2012-08-20
Decision date: 2012-10-09
Decision: Substantially Equivalent
Clearance type: Special
Location: Boulder, CO, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code JOH

product code JOH

Death: 42
Injury: 1,344
Malfunction: 5,608
Other: 1
Total: 6,995

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.