510(k) K193077

Shiley Adult Flexible Evac Tracheostomy Tube with TaperGuard Cuff by Covidien — Product Code JOH

K193077 is an FDA 510(k) premarket notification submitted by Covidien for the device "Shiley Adult Flexible Evac Tracheostomy Tube with TaperGuard Cuff". The FDA issued a decision of Substantially Equivalent on June 1, 2020. The device falls under product code JOH (Tube Tracheostomy And Tube Cuff), a Class II device regulated under 21 CFR 868.5800. Covidien has at least 10 other 510(k) clearances on record.