K260003
- 510(k) number
- K260003
- Device name
- KARL STORZ Mediastinoscopes and Instruments
- Applicant
- Karl Storz SE & CO. KG DE
- Product code
- EWY — Mediastinoscope, Surgical
- Decision date
- 2026-03-02
- Date received
- 2026-01-02
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Ear, Nose, Throat
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K260003.pdf
Official FDA record: K260003
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.