EWY — Mediastinoscope, Surgical Class II
FDA product code EWY covers "Mediastinoscope, Surgical", a Class II medical device regulated under 21 CFR 874.4720. Submissions are reviewed by the Ear, Nose, Throat panel. At least 11 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- EWY
- Device Class
- Class II
- Regulation Number
- 874.4720
- Submission Type
- Review Panel
- EN
- Medical Specialty
- Ear, Nose, Throat
- Implant
- No
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).
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K260003 | karl storz se and co. kg | KARL STORZ Mediastinoscopes and Instruments | March 2, 2026 |
| K213194 | karl storz endoscopy america | HD Mediastinoscope | June 23, 2022 |
| K202272 | karl storz endoscopy america | HD Mediastinoscope | May 11, 2021 |
| K170757 | boston-biomedical associates | Aegis Transit System | July 14, 2017 |
| K160171 | aegis surgical | Illuminated Mediastinal Access Port | February 26, 2016 |
| K141622 | aegis surgical | ILLUMINATED MEDIASTINOSCOPE | January 9, 2015 |
| K971166 | richard wolf medical instruments | OPTICAL MEDIASTINOSCOPE WITH PLUG-IN CONNECTION/OCULAR EYEPIECE | August 27, 1997 |
| K954910 | karl storz endoscopy-america | KARL STORZ OPTICAL MEDIASTINOSCOPE | November 3, 1995 |
| K930215 | olympus | FLEXIBLE TROCAR TUBES | March 16, 1993 |
| K913829 | olympus | OLYMPUS FLEXIBLE TIP THORACOSCOPE | November 22, 1991 |
| K912362 | olympus | OES THORACOSCOPE SYSTEM | October 24, 1991 |