K260003 is an FDA 510(k) clearance for the KARL STORZ Mediastinoscopes and Instruments. This device is classified as a Mediastinoscope, Surgical (Class II - Special Controls, product code EWY).
Submitted by Karl Storz SE & CO. KG (Tuttlingen, DE). The FDA issued a Cleared decision on March 2, 2026, 59 days after receiving the submission on January 2, 2026.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.4720. 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)..
| 510(k) Number | K260003 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 02, 2026 |
| Decision Date | March 02, 2026 |
| Days to Decision | 59 days |
| Submission Type | Traditional |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | Summary PDF |
| Product Code | EWY — Mediastinoscope, Surgical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 874.4720 |
| 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). |