JOH

Tube Tracheostomy And Tube Cuff

Product code
JOH
Device name
Tube Tracheostomy And Tube Cuff
Device class
Class 2
21 CFR
21 CFR 868.5800
Medical specialty
Anesthesiology
Marketing pathway
510(K)
Flag
Life-sustaining / life-supporting
Flag
Third-party review eligible
510(k) clearances (last 3 years)
1
Summaries archived here
1 (direct download)
510(k) clearances (all years, FDA)
109 (all years; only the last 3 years are listed here)

510(k) clearances, last 3 years (1)

Last three years. Most recent: 2025-12-29.

NumberDecision dateApplicantDevice nameSummary
K2513132025-12-29Covidien, LLCShiley™ Adult Flexible Tracheostomy Tube XLT with Ta…PDF

1 summaries are archived here for direct download.

Official FDA classification page: JOH
Classification and pathway per current FDA publications. Data from openFDA (CC0).