510(k) K260003
- Device
- KARL STORZ Mediastinoscopes and Instruments
- Applicant
- Karl Storz SE & CO. KG
- 510(k) number
- K260003
- Product code
- EWY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-03-02
- Date received
- 2026-01-02
- Regulation
- 874.4720
- Classification name
- Mediastinoscope, Surgical
- Medical specialty
- Ear, Nose, Throat
- Review panel
- Ear, Nose, Throat
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- Jordan Lydia Verla
- Address
- Dr.-Karl-Storz-Straße 34 Baden-Wurttemberg Tuttlingen DE 78532 78532
FDA Registration Numbers#
- 3006546082
- 9611616
- 3013247477
- 3011137372
- 1047843
- 9610617
- 3010202439
- 8010257
- 9611102
- 2020550
- 9610773
- 3003761012
- 8010935
- 3010041511
- 3014342096
- 3011050570
- 3012322232
- 9611503
- 3010707607
Source Documents#
Other 510(k) Records For Product Code EWY#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K213194 | HD Mediastinoscope | Karl Storz Endoscopy America, Inc. | 2022-06-23 |
| K202272 | HD Mediastinoscope | Karl Storz Endoscopy America, Inc. | 2021-05-11 |
| K170757 | Aegis Transit System | Boston-Biomedical Associates | 2017-07-14 |
| K160171 | Illuminated Mediastinal Access Port | Aegis Surgical, Ltd. | 2016-02-26 |
| K141622 | ILLUMINATED MEDIASTINOSCOPE | Aegis Surgical, Ltd. | 2015-01-09 |
| K971166 | OPTICAL MEDIASTINOSCOPE WITH PLUG-IN CONNECTION/OCULAR EYEPIECE | Richard Wolf Medical Instruments Corp. | 1997-08-27 |
| K954910 | KARL STORZ OPTICAL MEDIASTINOSCOPE | KARL STORZ Endoscopy-America, Inc. | 1995-11-03 |
| K930215 | FLEXIBLE TROCAR TUBES | Olympus Corp. | 1993-03-16 |
| K913829 | OLYMPUS FLEXIBLE TIP THORACOSCOPE | Olympus Corp. | 1991-11-22 |
| K912362 | OES THORACOSCOPE SYSTEM | Olympus Corp. | 1991-10-24 |