Panels › Ear, Nose, Throat › Product code EWY · Class 2
Mediastinoscope, Surgical
Regulation 874.4720
1510(k)s in 12 months (11 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in EWY
| Company | 510(k)s | Recalls |
|---|---|---|
| KARL STORZ Endoscopy-America, Inc. | 3 | 0 |
| Olympus Corp. | 3 | 0 |
| Aegis Surgical, Ltd. | 2 | 0 |
| Boston-Biomedical Associates | 1 | 0 |
| Karl Storz SE & CO. KG | 1 | 0 |
| Richard Wolf Medical Instruments Corp. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 2, 2026 | K260003 | KARL STORZ Mediastinoscopes and Instruments Karl Storz SE & CO. KG, DE | EWY |
| Jun 23, 2022 | K213194 | HD Mediastinoscope Karl Storz Endoscopy America, Inc. | EWY |
| May 11, 2021 | K202272 | HD Mediastinoscope Karl Storz Endoscopy America, Inc. | EWY |
| Jul 14, 2017 | K170757 | Aegis Transit System Boston-Biomedical Associates | EWY |
| Feb 26, 2016 | K160171 | Illuminated Mediastinal Access Port Aegis Surgical, Ltd. | EWY |
| Jan 9, 2015 | K141622 | ILLUMINATED MEDIASTINOSCOPE Aegis Surgical, Ltd. | EWY |
| Aug 27, 1997 | K971166 | OPTICAL MEDIASTINOSCOPE WITH PLUG-IN CONNECTION/OCULAR EYEPIECE Richard Wolf Medical Instruments Corp. | EWY |
| Nov 3, 1995 | K954910 | KARL STORZ OPTICAL MEDIASTINOSCOPE KARL STORZ Endoscopy-America, Inc. | EWY |
| Mar 16, 1993 | K930215 | FLEXIBLE TROCAR TUBES Olympus Corp. | EWY |
| Nov 22, 1991 | K913829 | OLYMPUS FLEXIBLE TIP THORACOSCOPE Olympus Corp. | EWY |
| Oct 24, 1991 | K912362 | OES THORACOSCOPE SYSTEM Olympus Corp. | EWY |
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