FDA Product Code EWY: Mediastinoscope, Surgical
Under FDA product code EWY, surgical mediastinoscopes are cleared for biopsy and visualization of the mediastinum during diagnostic thoracic surgery.
These rigid endoscopes are inserted through a small neck incision to visualize and biopsy mediastinal lymph nodes and masses for the staging of lung cancer and diagnosis of mediastinal pathology. Mediastinoscopy remains the gold standard for paratracheal lymph node sampling.
EWY devices are Class II medical devices, regulated under 21 CFR 874.4720 and reviewed by the FDA Ear, Nose & Throat panel.
Leading manufacturers include KARL STORZ Endoscopy-America, Inc. and Karl Storz SE & CO. KG.
List of Mediastinoscope, Surgical devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Mediastinoscope, Surgical devices (product code EWY). 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 Ear, Nose, Throat FDA review panel. Browse all Ear, Nose, Throat devices →