EWY
11 FDA 510(k) clearances · Product code
123 daysmedian time to decision
267 days90th percentile
11clearances measured
FDA profile
- Official device name
- Mediastinoscope, Surgical
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 874.4720
- Medical specialty
- Ear, Nose, Throat
- FDA definition
- If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
- Adverse events (MAUDE)
- 2006: 2 · 2016: 12 · 2023: 97 · 2024: 99 · 2025: 105 · 2026: 28
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| KARL STORZ Mediastinoscopes and Instruments (K260003) | Karl Storz SE & CO. KG | 2026-03-02 |
| HD Mediastinoscope (K213194) | Karl Storz Endoscopy America, Inc. | 2022-06-23 |
| HD Mediastinoscope (K202272) | Karl Storz Endoscopy America, Inc. | 2021-05-11 |
| Aegis Transit System (K170757) | Boston-Biomedical Associates | 2017-07-14 |
| Illuminated Mediastinal Access Port (K160171) | Aegis Surgical, Ltd. | 2016-02-26 |
| ILLUMINATED MEDIASTINOSCOPE (K141622) | Aegis Surgical, Ltd. | 2015-01-09 |
| OPTICAL MEDIASTINOSCOPE WITH PLUG-IN CONNECTION/OCULAR EYEPIECE (K971166) | Richard Wolf Medical Instruments Corp. | 1997-08-27 |
| KARL STORZ OPTICAL MEDIASTINOSCOPE (K954910) | KARL STORZ Endoscopy-America, Inc. | 1995-11-03 |
| FLEXIBLE TROCAR TUBES (K930215) | Olympus Corp. | 1993-03-16 |
| OLYMPUS FLEXIBLE TIP THORACOSCOPE (K913829) | Olympus Corp. | 1991-11-22 |
| OES THORACOSCOPE SYSTEM (K912362) | Olympus Corp. | 1991-10-24 |
Track EWY automatically
Every clearance here is in the API, with alerts when new ones post.