Mediastinoscope, Surgical
FDA product code EWY · Class II (moderate risk) · 21 CFR 874.4720 · Ear, Nose, Throat
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).
11510(k) clearances
0PMA approvals
0recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260003 | KARL STORZ Mediastinoscopes and InstrumentsEWY · Traditional | Karl Storz SE & CO. KG | 03/02/2026SE |
| K213194 | HD MediastinoscopeEWY · Traditional | Karl Storz Endoscopy America, Inc. | 06/23/2022SE |
| K202272 | HD MediastinoscopeEWY · Traditional | Karl Storz Endoscopy America, Inc. | 05/11/2021SE |
| K170757 | Aegis Transit SystemEWY · Traditional | Boston-Biomedical Associates | 07/14/2017SE |
| K160171 | Illuminated Mediastinal Access PortEWY · Special | Aegis Surgical, Ltd. | 02/26/2016SE |
| K141622 | Illuminated MediastinoscopeEWY · Traditional | Aegis Surgical, Ltd. | 01/09/2015SE |
| K971166 | Optical Mediastinoscope with Plug-In Connection/Ocular EyepieceEWY · Traditional | Richard Wolf Medical Instruments Corp. | 08/27/1997SE |
| K954910 | Karl Storz Optical MediastinoscopeEWY · Traditional | KARL STORZ Endoscopy-America, Inc. | 11/03/1995SE |
| K930215 | Flexible Trocar TubesEWY · Traditional | Olympus Corp. | 03/16/1993SE |
| K913829 | Olympus Flexible Tip ThoracoscopeEWY · Traditional | Olympus Corp. | 11/22/1991SE |
| K912362 | Oes Thoracoscope SystemEWY · Traditional | Olympus Corp. | 10/24/1991SE |