FDA Product Code EOB: Nasopharyngoscope (flexible Or Rigid)
Visualization of the nasopharynx is essential in the evaluation of nasal, sinus, and upper airway conditions. FDA product code EOB covers flexible and rigid nasopharyngoscopes and their accessories.
These endoscopes allow ENT specialists to directly inspect the nasal cavity, nasopharynx, and hypopharynx for the diagnosis of nasal polyps, sinusitis, tumors, and voice disorders, and to guide procedures including biopsy and intubation.
EOB devices are Class II medical devices, regulated under 21 CFR 874.4760 and reviewed by the FDA Ear, Nose & Throat panel.
Leading manufacturers include Olympus Medical Systems Corporation, Olympus Medical Systems Corp. and Shenzhen HugeMed Medical Technical Development Co., Ltd..
FDA 510(k) Cleared Nasopharyngoscope (flexible Or Rigid) Devices (Product Code EOB)
About Product Code EOB - Regulatory Context
510(k) Submission Activity
160 total 510(k) submissions under product code EOB since 1987, with 160 receiving FDA clearance (average review time: 137 days).
Submission volume has declined in recent years - 6 submissions in the last 24 months compared to 10 in the prior period.
FDA Review Time
Recent submissions under EOB have taken an average of 241 days to reach a decision - up from 133 days historically. Manufacturers should account for longer review timelines in current project planning.
EOB devices are reviewed by the Ear, Nose, Throat panel. Browse all Ear, Nose, Throat devices →