KARL STORZ Mediastinoscopes and Instruments
FDA 510(k) K260003 · Karl Storz SE & CO. KG
510(k) numberK260003
Submission
- Device name
- KARL STORZ Mediastinoscopes and Instruments
- Applicant
- Karl Storz SE & CO. KG
Tuttlingen, DE - Received
- January 2, 2026
- Decision date
- March 2, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- EWY – Mediastinoscope, Surgical
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 874.4720
- Specialty
- 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).
Other 510(k)s with product code EWY
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
More from Olympus Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K260884 | UNIDRIVE Select SystemGCJ · Traditional | 09/01/2026SE |
| K254103 | HOPKINS Telescopes for ArthroscopyHRX · Traditional | 08/26/2026SE |
| K260209 | ENDOFLATOR+; Smart Smoke EvacuationHIF · Traditional | 08/19/2026SE |
| K261706 | Endomat Select (UP220)HIG · Traditional | 07/16/2026SE |
| K252800 | KARL STORZ Endoscopic Accessories for UrologyOCZ · Traditional | 06/03/2026SE |
| K254228 | KARL STORZ Trocars with Valve SealsGCJ · Traditional | 05/11/2026SE |
| K254242 | KARL STORZ ICG Imaging System with RUBINA® LensOWN · Traditional | 02/26/2026SE |
| K253972 | IMAGE1 (TC400US); X-to-4U Adapter (TC040)OWN · Traditional | 02/12/2026SE |
| K251731 | KARL STORZ Flexible Intubation Video Endoscope Sterile (FIVE-S) (0916612)EOQ · Special | 12/05/2025SE |
| K250927 | KARL STORZ Cholangiography SetGCJ · Traditional | 11/22/2025SE |
Questions and answers
When was KARL STORZ Mediastinoscopes and Instruments cleared by the FDA?
KARL STORZ Mediastinoscopes and Instruments (K260003) received a 510(k) decision of Substantially Equivalent on March 2, 2026, 59 days after the submission was received.
What is the product code of K260003?
The FDA product code is EWY – Mediastinoscope, Surgical, a Class II (moderate risk) device regulated under 21 CFR 874.4720.