Brush, Cleaning, Tracheal Tube

FDA product code EPE · Class I (low risk) · 21 CFR 868.5795 · Anesthesiology

2510(k) clearances
0PMA approvals
1recalls
GMP exemptexempt from GMP rules

Manufacturers

510(k) clearances

510(k)DeviceApplicantDecision
K863635Updated Sterile Endotracheal BrushesEPE · Traditional Biological & Environmental Control Laboratories11/03/1986SE
K862563Tracheostomy Cleansing SolutionEPE · Traditional Clinipad Corp.07/15/1986SE

Recalls

RecallProductFirmInitiated
Z-1427-2024 Class IICenturion STERILE TRACH BRUSH, Product Code 6225STProduct may have a weak seal which may result in a breach of sterility of the contents if the seal fails.… MEDLINE INDUSTRIES, LP - Northfield02/23/2024Open, Classified