FDA Product Code KTI: Bronchoscope Accessory
Under FDA product code KTI, bronchoscope accessories are cleared for use with bronchoscopic procedures in pulmonology and critical care.
These accessories include biopsy forceps, brushes, needles, suction catheters, and balloon catheters passed through the working channel of a bronchoscope to perform tissue sampling, foreign body removal, and therapeutic interventions within the airways.
KTI devices are Class II medical devices, regulated under 21 CFR 874.4680 and reviewed by the FDA Anesthesiology panel.
Leading manufacturers include Micro-Tech (Nanjing) Co., Ltd., Merit Medical Systems, Inc. and Olympus Medical Systems Corp..
List of Bronchoscope Accessory devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Bronchoscope Accessory devices (product code KTI). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.
These devices fall under the Anesthesiology FDA review panel. Browse all Anesthesiology devices →