FDA Product Code EOQ: Bronchoscope (flexible Or Rigid)
FDA product code EOQ covers flexible and rigid bronchoscopes and their accessories.
These endoscopic instruments allow clinicians to directly visualize the airways — from the larynx to the segmental bronchi — for diagnostic and therapeutic purposes. They are used in the evaluation of lung lesions, foreign body removal, airway management, and bronchial lavage.
EOQ devices are Class II medical devices, regulated under 21 CFR 874.4680 and reviewed by the FDA Ear, Nose & Throat panel.
Leading manufacturers include Ambu A/S, Intuitive Surgical, Inc. and Olympus Medical Systems Corp..
FDA 510(k) Cleared Bronchoscope (flexible Or Rigid) Devices (Product Code EOQ)
About Product Code EOQ - Regulatory Context
510(k) Submission Activity
237 total 510(k) submissions under product code EOQ since 1976, with 237 receiving FDA clearance (average review time: 123 days).
Submission volume has remained relatively stable over the observed period, with 26 submissions in the last 24 months.
FDA Review Time
Recent submissions under EOQ have taken an average of 149 days to reach a decision - up from 119 days historically. Manufacturers should account for longer review timelines in current project planning.
EOQ devices are reviewed by the Ear, Nose, Throat panel. Browse all Ear, Nose, Throat devices →