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.
FDA 510(k) Cleared Mediastinoscope, Surgical Devices (Product Code EWY)
About Product Code EWY - Regulatory Context
510(k) Submission Activity
11 total 510(k) submissions under product code EWY since 1991, with 11 receiving FDA clearance (average review time: 128 days).
Submission volume has remained relatively stable over the observed period, with 1 submissions in the last 24 months.
FDA Review Time
Recent submissions under EWY have taken an average of 59 days to reach a decision - down from 135 days historically, suggesting improved FDA processing for this classification.
EWY devices are reviewed by the Ear, Nose, Throat panel. Browse all Ear, Nose, Throat devices →